Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01318278
• Collaborator: Thrasher Research Fund (Other)
• Enrollment: 70
• Location: 1
• Arms: 3
• Duration (Months): 30.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of their lives. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Research is being conducted to try to find the best medication to use in these situations. Dopamine is often used first, but it does not always prove to be effective, and it has several concerning side effects. This study will look at vasopressin, which has fewer side effects, as a first-line medication for low blood pressure in extremely low birth weight infants.

Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in preterm, extremely low birth weight infants who have hypotension within the first 24 hours of life. We will specifically look at its ability to raise blood pressure values, improve clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.

Condition or Disease	Intervention/Treatment	Phase
Hypotension	Drug: Dopamine; Drug: Arginine Vasopressin	N/A

Detailed Description

Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase. Severe, prolonged hypotension contributes to cellular dysfunction and cell death. Systemic hypotension affects close to half of all ELBW infants and a significant portion of LBW infants. The true definition of hypotension remains to be a question. There is a linear association between birth weight, gestational age, and mean blood pressure but blood pressure can vary significantly in the first day of life. The critical period tends to be the first 24-36 hours of life as blood pressure tends to rise significantly in the first 72 hours of life regardless of gestational age. Preterm infants suffering from hypotension have a higher incidence and increased severity of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and long-term neurodevelopmental sequelae compared to normotensive preterm infants. Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Dopamine is commonly used as first-line therapy, but issues with efficacy and its side effect profile have lessened its favorability over the years. Few studies compare dopamine to other agents as a first -line treatment. This study hopes to contribute to the literature information on vasopressin as a potential first-line agent for treatment of neonatal hypotension in low birth weight infants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dopamine treatment Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min	Drug: Dopamine; dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy; Other Names: Dopamine Hydrochloride
Active Comparator: Vasopressin treatment Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr	Drug: Arginine Vasopressin; vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy; Other Names: Vasopressin Antidiuretic Hormone (ADH) Pitressin (US brand name) Pressyn;Pressyn AR (Canadian brand names) Argipressin
No Intervention: Comparison Arm Infants who did not require vasopressor support for hypotension during the first 24 hours of life

Outcome Measures

Primary Outcome Measures

1. Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life [24 hours of life]

   Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP

Secondary Outcome Measures

1. Heart Rate Change From Baseline [96 hours or until hypotension completely resolved and medications stopped]

   Heart rate change from baseline during study drug administration

2. Acid-base Status [96 hours or until hypotension resolved and medication completely stopped]

3. Hyponatremia [96 hours or until medication completely stopped]

4. Urine Output [96 hours or until hypotension resolved and medication completely stopped]

5. Evidence of Ischemic Changes [96 hours or until medication completely stopped]

   Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.

6. Necrotizing Enterocolitis [until hospital discharge, up to 12 weeks]

7. Ventilator Days [Until hospital discharge, up to 15 months]

8. Presence of Patent Ductus Arteriosus (PDA) [until hospital discharge, up to 12 weeks]

9. Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound [Until hospital discharge, up to 15 months]

10. Retinopathy of Prematurity Stage 3 or Higher [Until hospital discharge, up to 15 months]

    All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis. Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages.

11. Presence of Bronchopulmonary Dysplasia (BPD) [36 weeks postmenstrual age]

    Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD

12. All Cause Mortality [admission to hospital discharge, up to 15 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infants less than 24 hours of age

• Infants with birth weight of <1001 grams and/or gestational age of <29 weeks

• Not initiated on any continuous pressor therapy prior to enrollment

• Intravenous line in place

• Outborn infants meeting eligibility criteria

Exclusion Criteria:

• Infants not meeting eligibility criteria

• Infants with life-threatening congenital defects

• Infants with congenital hydrops

• Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)

• Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• Thrasher Research Fund

Investigators

• Principal Investigator: Danielle R Rios, M.D., Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danielle Rios, Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT01318278
• Other Study ID Numbers: H-27661
• First Posted: Mar 18, 2011
• Last Update Posted: Feb 20, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Danielle Rios, Assistant Professor, Baylor College of Medicine: Hypotension; Low blood pressure; Neonate; Dopamine; Vasopressin; Extremely Low Birth Weight Infant
• Additional relevant MeSH terms: Hypotension; Birth Weight; Dopamine; Vasopressins; Arginine Vasopressin

Study Results

Participant Flow

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Period Title: Overall Study
STARTED	10	10	50
COMPLETED	10	10	50
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm	Total
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life	Total of all reporting groups
Overall Participants	10	10	50	70
Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	25.1 (1)	25.7 (2)	25.6 (1)	25.6 (1.4)
Sex: Female, Male (Count of Participants)
Female	5 50%	4 40%	28 56%	37 52.9%
Male	5 50%	6 60%	22 44%	33 47.1%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life
Description	Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
Time Frame	24 hours of life

Outcome Measure Data

Analysis Population Description

This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy
Measure Participants	10	10
Number [participants]	9 90%	9 90%

2. Secondary Outcome

Title	Heart Rate Change From Baseline
Description	Heart rate change from baseline during study drug administration
Time Frame	96 hours or until hypotension completely resolved and medications stopped

Outcome Measure Data

Analysis Population Description

This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy
Measure Participants	10	10
Mean (Standard Deviation) [beats per minute]	31 (19)	0 (10)

3. Secondary Outcome

Title	Acid-base Status
Time Frame	96 hours or until hypotension resolved and medication completely stopped

Outcome Measure Data

Analysis Population Description

Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Group
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants not diagnosed with hypotension in first 24 hours
Measure Participants	10	10	50
Mean (Standard Deviation) [pH]	7.18 (.07)	7.2 (.07)	7.25 (.09)

4. Secondary Outcome

Title	Hyponatremia
Time Frame	96 hours or until medication completely stopped

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	3 30%	3 30%	11 22%

5. Secondary Outcome

Title	Urine Output
Time Frame	96 hours or until hypotension resolved and medication completely stopped

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Mean (Standard Deviation) [ml/kg/hr]	4.4 (1.4)	3.5 (1.4)	3.9 (1.4)

6. Secondary Outcome

Title	Evidence of Ischemic Changes
Description	Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.
Time Frame	96 hours or until medication completely stopped

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Necrotizing Enterocolitis
Time Frame	until hospital discharge, up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	0 0%	1 10%	2 4%

8. Secondary Outcome

Title	Ventilator Days
Time Frame	Until hospital discharge, up to 15 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Median (Inter-Quartile Range) [days]	52	45.5	17.5

9. Secondary Outcome

Title	Presence of Patent Ductus Arteriosus (PDA)
Time Frame	until hospital discharge, up to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	5 50%	6 60%	34 68%

10. Secondary Outcome

Title	Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound
Time Frame	Until hospital discharge, up to 15 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	3 30%	3 30%	6 12%

11. Secondary Outcome

Title	Retinopathy of Prematurity Stage 3 or Higher
Description	All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis. Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages.
Time Frame	Until hospital discharge, up to 15 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	3 30%	2 20%	4 8%

12. Secondary Outcome

Title	Presence of Bronchopulmonary Dysplasia (BPD)
Description	Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
Time Frame	36 weeks postmenstrual age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	8 80%	4 40%	31 62%

13. Secondary Outcome

Title	All Cause Mortality
Time Frame	admission to hospital discharge, up to 15 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dopamine Treatment	Vasopressin Treatment	Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy	Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy	Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Measure Participants	10	10	50
Number [participants]	2 20%	4 40%	10 20%

Adverse Events

Time Frame	Participants were followed for the duration of hospital stay, up to 15 months
Arm/Group Title	Dopamine Treatment		Vasopressin Treatment		Comparison Arm
Arm/Group Description	Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy		Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy		Infants who did not require vasopressor support for hypotension during the first 24 hours of life
All Cause Mortality
	Dopamine Treatment		Vasopressin Treatment		Comparison Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/10 (20%)		4/10 (40%)		10/50 (20%)
Serious Adverse Events
	Dopamine Treatment		Vasopressin Treatment		Comparison Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/10 (80%)		7/10 (70%)		22/50 (44%)
Gastrointestinal disorders
Necrotizing Enterocolitis	1/10 (10%)		0/10 (0%)		7/50 (14%)
Bowel Perforation	3/10 (30%)		2/10 (20%)		4/50 (8%)
Infections and infestations
Sepsis	4/10 (40%)		5/10 (50%)		11/50 (22%)
Other (Not Including Serious) Adverse Events
	Dopamine Treatment		Vasopressin Treatment		Comparison Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		4/10 (40%)		11/50 (22%)
Renal and urinary disorders
Hyponatremia	3/10 (30%)		4/10 (40%)		11/50 (22%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.