Hydrocortisone for Term Hypotension
Sponsor
NICHD Neonatal Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT01954056
Collaborator
National Center for Research Resources (NCRR) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
12
18
2
45
0.7
0
Study Details
Study Description
Brief Summary
This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age.
This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the Neonatal Research Network (NRN). This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
Actual Study Start Date
:
Jun 19, 2014
Actual Primary Completion Date
:
Mar 20, 2018
Actual Study Completion Date
:
Mar 20, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hydrocortisone hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line |
Drug: Hydrocortisone
• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
| Placebo Comparator: Placebo Saline placebo |
Drug: Placebo
7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Outcome Measures
Primary Outcome Measures
- Death [Birth to 22-26 months corrected gestational age]
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
- Number of Participants With Neurodevelopmental Impairment [Birth to 22-26 months corrected gestational age]
This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
- Number of Participants With Death or Neurodevelopmental Impairment [Birth to 22-26 months corrected gestational age]
A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Secondary Outcome Measures
- Duration of Mechanical Ventilation [Birth to 60 days of life]
This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
- Days to Full Feeds [Birth to 60 days of life]
The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.
- Number of Participants With Need for Gastronomy Tube [Birth to 60 days of life]
This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No
- Duration of Oxygen Requirement [Birth to 60 days of life]
This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
- Number of Participants With Need for Home Oxygen [Birth to 60 days of life]
This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
- Hospital Length of Stay [Birth to 60 days of life]
This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.
- Number of Participants With Renal Insufficiency [Birth to 60 days of life]
This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment
- Number of Participants With Necrotizing Enterocolitis [Birth to 60 days of life]
This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery
- Number of Participants With Need for ECMO Therapy [Birth to 60 days of life]
This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.
- Number of Participants With Inotrope Exposure [24 hours prior to study drug administration through 3 days post study drug administration.]
This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
- Inotrope Duration [24 hours prior to study drug administration through 3 days post study drug administration.]
This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.
- Maximum Inotrope Dose [From start of study drug administration (7 days) through 3 days post study drug administration.]
This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.
- Oxygenation Index [Birth to 60 days of life]
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.
- Respiratory Severity [Birth to 60 days of life]
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.
- Number of Participants With Fluid Boluses Given [Birth to 60 days of life]
This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.
- Number of Boluses Given [Birth to 60 days of life]
The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Eligibility Criteria
Criteria
Ages Eligible for Study:
34 Weeks
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Gestational age greater than or equal to 34 weeks at birth
-
Admitted to the center NICU by 48 hours of age
-
Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age
Exclusion Criteria:
-
Receiving ECMO
-
Intubated for the sole purpose of anticipated surgery or airway anomalies
-
Treatment will be limited based on poor prognosis
-
Receiving dexamethasone or hydrocortisone
-
Receiving ibuprofen or indomethacin
-
Congenital heart disease
-
Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
-
Pituitary hypoplasia or congenital adrenal hyperplasia
-
Any chromosomal disorder
-
Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile
-
Initiation of whole body cooling for moderate or severe neonatal encephalopathy
-
Brain disorders or any other known structural abnormality
-
Major anomalies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | University of California - Los Angeles | Los Angeles | California | United States | 90025 |
| 3 | Stanford University | Palo Alto | California | United States | 94304 |
| 4 | Emory University | Atlanta | Georgia | United States | 30303 |
| 5 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 6 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 7 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 8 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 9 | University of New Mexico | Albuquerque | New Mexico | United States | 87131 |
| 10 | University of Rochester | Rochester | New York | United States | 14642 |
| 11 | RTI International | Durham | North Carolina | United States | 27705 |
| 12 | Duke University | Durham | North Carolina | United States | 27710 |
| 13 | Cincinnati Children's Medical Center | Cincinnati | Ohio | United States | 45267 |
| 14 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 15 | Research Institute at Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 16 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 17 | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75235 |
| 18 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- NICHD Neonatal Research Network
- National Center for Research Resources (NCRR)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Michele C Walsh, MD, Case Western Reserve University, Rainbow Babies and Children's Hospital
- Principal Investigator: Seetha Shankaran, MD, Wayne State University
- Principal Investigator: Abbot R Laptook, MD, Brown University, Women & Infants Hospital of Rhode Island
- Principal Investigator: Ron N Goldberg, MD, Duke University
- Principal Investigator: Barbara J Stoll, MD, Emory University
- Principal Investigator: Brenda B Poindexter, MD, MS, Indiana University
- Principal Investigator: Abhik Das, PhD, RTI International
- Principal Investigator: Krisa P Van Meurs, MD, Stanford University
- Principal Investigator: Kurt Schibler, MD, Children's Hospital Medical Center, Cincinnati
- Principal Investigator: Waldemar Carlo, MD, University of Alabama at Birmingham
- Principal Investigator: Edward F Bell, MD, Michele C Walsh, MD Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Seetha Shankaran, MD Study Principal Investigator Wayne State University Abbot R Laptook, MD Study Principal Investigator Brown Un
- Study Chair: Erika Fernandez, MD, University of New Mexico
- Principal Investigator: Myra Wycoff, MD, University of Texas, Southwestern Medical Center at Dallas
- Principal Investigator: Kathleen A Kennedy, MD, MPH, The University of Texas Health Science Center, Houston
- Principal Investigator: Barbara Schmidt, MD, University of Pennsylvania
- Principal Investigator: Carl T D'Angio, MD, University of Rochester
- Principal Investigator: Uday Devaskar, MD, University of California, Los Angeles
- Principal Investigator: Leif Nelin, MD, Research Institute at Nationwide Children's Hospital
- Principal Investigator: William Truog, MD, Children's Mercy Hospital Kansas City
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01954056
Other Study ID Numbers:
- NICHD-NRN-0052
- U10HD021364
- U10HD040689
- U10HD021385
- U10HD027851
- U10HD027853
- U10HD027856
- U10HD027904
- U10HD027880
- U10HD034216
- U10HD021373
- U10HD040492
- U10HD053109
- U10HD040461
- U10HD068244
- U10HD068263
- U10HD068270
- U10HD068278
- U10HD068284
- U10HD036790
First Posted:
Oct 1, 2013
Last Update Posted:
Jul 6, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by NICHD Neonatal Research Network
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Infants < 48 hours of age and born at ≥ 34 weeks gestational age were screened for the study between June 2014 and July 2015 at the 16 NRN Clinical Centers. Those who were intubated and on mechanical ventilation for at least 2 hours within the first 72 hours were considered for the study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Period Title: Birth to 60 Days of Life | ||
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Birth to 60 Days of Life | ||
| STARTED | 6 | 6 |
| COMPLETED | 5 | 6 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Hydrocortisone | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Total of all reporting groups |
| Overall Participants | 6 | 6 | 12 |
| Age (weeks) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [weeks] |
37.5
(2.2)
|
39.4
(1.8)
|
38.4
(2.2)
|
| Sex/Gender, Customized (Count of Participants) | |||
| Male |
4
66.7%
|
2
33.3%
|
6
50%
|
| Female |
2
33.3%
|
4
66.7%
|
6
50%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Hispanic or Latino |
1
16.7%
|
1
16.7%
|
2
16.7%
|
| Not Hispanic or Latino |
3
50%
|
5
83.3%
|
8
66.7%
|
| Unknown or Not Reported |
2
33.3%
|
0
0%
|
2
16.7%
|
| Maternal Race (Count of Participants) | |||
| Black |
3
50%
|
2
33.3%
|
5
41.7%
|
| White |
3
50%
|
2
33.3%
|
5
41.7%
|
| More than one race |
0
0%
|
1
16.7%
|
1
8.3%
|
| Unknown or Not Reported |
0
0%
|
1
16.7%
|
1
8.3%
|
| Maternal Age, Continuous (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
32.2
(7.6)
|
26.7
(9.5)
|
29.4
(8.7)
|
| Birth weight (grams) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [grams] |
3415
(669.3)
|
3120.3
(541)
|
3267.7
(600.3)
|
| Length (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
50.1
(2.3)
|
49.8
(1.5)
|
49.9
(1.9)
|
| Head circumference (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
34.4
(2)
|
34.5
(3.5)
|
34.5
(2.7)
|
| Apgar score less than 3 at 1 minute (Count of Participants) | |||
| No |
2
33.3%
|
4
66.7%
|
6
50%
|
| Yes |
4
66.7%
|
2
33.3%
|
6
50%
|
| Apgar score less than 3 at 5 minutes (Count of Participants) | |||
| No |
5
83.3%
|
6
100%
|
11
91.7%
|
| Yes |
1
16.7%
|
0
0%
|
1
8.3%
|
| Apgar score less than 3 at 10 minutes (Count of Participants) | |||
| No |
3
50%
|
3
50%
|
6
50%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
| Unknown |
3
50%
|
3
50%
|
6
50%
|
| Infant Outborn (Count of Participants) | |||
| No |
4
66.7%
|
2
33.3%
|
6
50%
|
| Yes |
2
33.3%
|
4
66.7%
|
6
50%
|
| Oxygen (Count of Participants) | |||
| Yes |
6
100%
|
6
100%
|
12
100%
|
| No |
0
0%
|
0
0%
|
0
0%
|
| Bagging and Mask (Count of Participants) | |||
| No |
1
16.7%
|
2
33.3%
|
3
25%
|
| Yes |
5
83.3%
|
4
66.7%
|
9
75%
|
| Chest Compression (Count of Participants) | |||
| No |
5
83.3%
|
5
83.3%
|
10
83.3%
|
| Yes |
1
16.7%
|
1
16.7%
|
2
16.7%
|
| Intubation (Count of Participants) | |||
| No |
4
66.7%
|
1
16.7%
|
5
41.7%
|
| Yes |
2
33.3%
|
5
83.3%
|
7
58.3%
|
| Medications or volume expanders (Count of Participants) | |||
| No |
5
83.3%
|
3
50%
|
8
66.7%
|
| Yes |
1
16.7%
|
3
50%
|
4
33.3%
|
| Maternal marital Status (Count of Participants) | |||
| Married |
1
16.7%
|
1
16.7%
|
2
16.7%
|
| Single |
5
83.3%
|
5
83.3%
|
10
83.3%
|
| Maternal gravida (Number of pregnancies) [Median (Full Range) ] | |||
| Median (Full Range) [Number of pregnancies] |
2.5
|
1
|
2
|
| Maternal parity (Number of successful pregnancies) [Median (Full Range) ] | |||
| Median (Full Range) [Number of successful pregnancies] |
2.5
|
1
|
2
|
| Maternal multiple birth (Count of Participants) | |||
| No |
6
100%
|
6
100%
|
12
100%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
| Maternal prenatal care (Count of Participants) | |||
| No |
2
33.3%
|
1
16.7%
|
3
25%
|
| Yes |
4
66.7%
|
5
83.3%
|
9
75%
|
| Maternal antenatal steroids (Count of Participants) | |||
| No |
6
100%
|
6
100%
|
12
100%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
| Maternal documented chorioamnionitis (Count of Participants) | |||
| No |
5
83.3%
|
6
100%
|
11
91.7%
|
| Yes |
1
16.7%
|
0
0%
|
1
8.3%
|
| Placental pathology performed (Count of Participants) | |||
| No |
1
16.7%
|
1
16.7%
|
2
16.7%
|
| Yes |
2
33.3%
|
3
50%
|
5
41.7%
|
| Unknown |
3
50%
|
2
33.3%
|
5
41.7%
|
| Final mode of delivery (Count of Participants) | |||
| Vaginal vertex |
3
50%
|
2
33.3%
|
5
41.7%
|
| Cesarean section |
3
50%
|
3
50%
|
6
50%
|
| Unknown |
0
0%
|
1
16.7%
|
1
8.3%
|
Outcome Measures
| Title | Death |
|---|---|
| Description | This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No. |
| Time Frame | Birth to 22-26 months corrected gestational age |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| Title | Number of Participants With Neurodevelopmental Impairment |
|---|---|
| Description | This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No. |
| Time Frame | Birth to 22-26 months corrected gestational age |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Yes |
3
50%
|
3
50%
|
| No |
3
50%
|
3
50%
|
| Title | Number of Participants With Death or Neurodevelopmental Impairment |
|---|---|
| Description | A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age. |
| Time Frame | Birth to 22-26 months corrected gestational age |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Yes |
3
50%
|
3
50%
|
| No |
3
50%
|
3
50%
|
| Title | Duration of Mechanical Ventilation |
|---|---|
| Description | This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Median (Full Range) [Days] |
8
|
11
|
| Title | Days to Full Feeds |
|---|---|
| Description | The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. Excludes 4 infants (Hydrocortisone: 1, Placebo: 3) without information on full feeds. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 5 | 3 |
| Median (Full Range) [Days] |
16
|
18
|
| Title | Number of Participants With Need for Gastronomy Tube |
|---|---|
| Description | This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| Title | Duration of Oxygen Requirement |
|---|---|
| Description | This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Median (Full Range) [Days] |
15.5
|
18
|
| Title | Number of Participants With Need for Home Oxygen |
|---|---|
| Description | This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 5 | 6 |
| No |
5
83.3%
|
4
66.7%
|
| Yes |
0
0%
|
2
33.3%
|
| Title | Hospital Length of Stay |
|---|---|
| Description | This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 5 | 5 |
| Median (Full Range) [Days] |
27
|
24
|
| Title | Number of Participants With Renal Insufficiency |
|---|---|
| Description | This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| Title | Number of Participants With Necrotizing Enterocolitis |
|---|---|
| Description | This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
5
83.3%
|
6
100%
|
| Yes |
1
16.7%
|
0
0%
|
| Title | Number of Participants With Need for ECMO Therapy |
|---|---|
| Description | This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| Title | Number of Participants With Inotrope Exposure |
|---|---|
| Description | This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug. |
| Time Frame | 24 hours prior to study drug administration through 3 days post study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
4
66.7%
|
4
66.7%
|
| Yes |
2
33.3%
|
2
33.3%
|
| No |
5
83.3%
|
4
66.7%
|
| Yes |
1
16.7%
|
2
33.3%
|
| No |
5
83.3%
|
5
83.3%
|
| Yes |
1
16.7%
|
1
16.7%
|
| Title | Inotrope Duration |
|---|---|
| Description | This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug. |
| Time Frame | 24 hours prior to study drug administration through 3 days post study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Median (Full Range) [days] |
3
|
3
|
| Title | Maximum Inotrope Dose |
|---|---|
| Description | This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine. |
| Time Frame | From start of study drug administration (7 days) through 3 days post study drug administration. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [mcg/kg/min] |
9.5
(2.9)
|
14.7
(12.6)
|
| Title | Oxygenation Index |
|---|---|
| Description | This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Before dose 1 |
10.7
(6.1)
|
14.5
(8.6)
|
| Before dose 5 |
7
(3.7)
|
14.9
(6.9)
|
| Before dose 9 |
6.6
(2.1)
|
10.4
(5.3)
|
| Before dose 13 |
5.8
(3)
|
9.2
(4.2)
|
| Before dose 15 |
4.7
(2)
|
9.3
(0.8)
|
| Before dose 17 |
5.9
(3.2)
|
7.9
(1.1)
|
| Before dose 18 |
3.7
|
9.1
(4.6)
|
| Title | Respiratory Severity |
|---|---|
| Description | This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| Before dose 1 |
726.8
(371)
|
1184.7
(518.7)
|
| Before dose 5 |
518.8
(272.5)
|
1041.2
(432.6)
|
| Before dose 9 |
531.6
(196.5)
|
925.8
(611.8)
|
| Before dose 13 |
414.6
(230)
|
776.8
(411.2)
|
| Before dose 15 |
423
(158.8)
|
899
(453.4)
|
| Before dose 17 |
323
(117.8)
|
785.8
(463.2)
|
| Before dose 18 |
308.5
(139.3)
|
694.7
(274)
|
| Title | Number of Participants With Fluid Boluses Given |
|---|---|
| Description | This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No. |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 6 | 6 |
| No |
2
33.3%
|
2
33.3%
|
| Yes |
4
66.7%
|
4
66.7%
|
| No |
5
83.3%
|
4
66.7%
|
| Yes |
1
16.7%
|
2
33.3%
|
| No |
5
83.3%
|
5
83.3%
|
| Yes |
1
16.7%
|
1
16.7%
|
| No |
5
83.3%
|
6
100%
|
| Yes |
1
16.7%
|
0
0%
|
| No |
6
100%
|
4
66.7%
|
| Yes |
0
0%
|
1
16.7%
|
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| No |
6
100%
|
6
100%
|
| Yes |
0
0%
|
0
0%
|
| Title | Number of Boluses Given |
|---|---|
| Description | The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life |
| Time Frame | Birth to 60 days of life |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. |
| Arm/Group Title | Hydrocortisone | Placebo |
|---|---|---|
| Arm/Group Description | Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
| Measure Participants | 5 | 5 |
| Before dose 1 |
3
|
3
|
| Before dose 5 |
2
|
1
|
| Before dose 9 |
2
|
1
|
| Before dose 13 |
1
|
|
| Before dose 15 |
1
|
Adverse Events
| Time Frame | 10 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Hydrocortisone | Placebo | ||
| Arm/Group Description | hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose | ||
All Cause Mortality |
||||
| Hydrocortisone | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/6 (0%) | ||
Serious Adverse Events |
||||
| Hydrocortisone | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 0/6 (0%) | ||
| Blood and lymphatic system disorders | ||||
| HYPERBILIRUBINEMIA REQUIRING EXCHANGE TRANSFUSION | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||
| HYPERTENSION, NEW AND SUSTAINED | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 |
| Endocrine disorders | ||||
| ADRENAL INSUFFICIENCY | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Hydrocortisone | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 1/6 (16.7%) | ||
| Cardiac disorders | ||||
| ATRIAL TACHYCARDIA | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Limitations/Caveats
The study was closed to enrollment after 12 participants due to slow recruitment.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Investigators must adhere to the Neonatal Research Network Publication policies
Results Point of Contact
| Name/Title | Dr. Kristi Watterberg |
|---|---|
| Organization | University of New Mexico |
| Phone | 505-272-8609 |
| KWatterberg@salud.unm.edu |
Responsible Party:
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01954056
Other Study ID Numbers:
- NICHD-NRN-0052
- U10HD021364
- U10HD040689
- U10HD021385
- U10HD027851
- U10HD027853
- U10HD027856
- U10HD027904
- U10HD027880
- U10HD034216
- U10HD021373
- U10HD040492
- U10HD053109
- U10HD040461
- U10HD068244
- U10HD068263
- U10HD068270
- U10HD068278
- U10HD068284
- U10HD036790
First Posted:
Oct 1, 2013
Last Update Posted:
Jul 6, 2021
Last Verified:
Jul 1, 2021