Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00669383
• Collaborator: American Lung Association (Other)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 101
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Compliance; Functional Residual Capacity; Pulmonary Function Testing	Drug: betamethasone; Drug: placebo	N/A

Detailed Description

The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, remained undelivered after 14 days and at < 34 weeks of gestation, and were then randomized to either a rescue course of antenatal corticosteroids or to a rescue course of placebo. In addition, follow-up pulmonary function tests, clinical outcomes, growth parameters, and the neurodevelopmental outcome of these infants will be followed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses	Drug: betamethasone; 12 mg IM q 24 hours x 2 doses; Other Names: Celestone
Placebo Comparator: B Placebo dose intramuscular q 24 hours x 2 doses	Drug: placebo; Placebo IM q 24 hours x 2 doses

Outcome Measures

Primary Outcome Measures

1. Measurements of Functional Residual Capacity in Preterm Infants. [Within first 72 hours after birth]

2. Measurements of Respiratory Compliance (Crs) in Preterm Infants. [Within first 72 hours after birth]

Secondary Outcome Measures

1. FiO2 [During initial hospital stay and planned follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Greater than 14 days after first course of antenatal steroids;

• Less than 34 weeks of gestation;

• Identified by primary physician as continued risk for preterm delivery;

• Informed consent

Exclusion Criteria:

• Major congenital anomalies

• Multiple gestation of triplets or greater

• Mother with insulin dependent diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97219

Sponsors and Collaborators

• Oregon Health and Science University
• American Lung Association

Investigators

• Principal Investigator: Cynthia McEvoy, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00669383
• Other Study ID Numbers: OHSU eRIB#1845
• First Posted: Apr 30, 2008
• Last Update Posted: Feb 22, 2019
• Last Verified: Oct 1, 2018

• Keywords provided by Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University: premature delivery; respiratory distress syndrome
• Additional relevant MeSH terms: Betamethasone

Study Results

Participant Flow

Recruitment Details	This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.
Pre-assignment Detail	Women who showed no further signs of preterm delivery after consent were not randomized.

Arm/Group Title	A (Betamethasone)	B (Placebo)
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	Placebo dose IM q 24 hours x 2 doses
Period Title: Overall Study
STARTED	44	41
COMPLETED	44	41
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	A (Betamethasone)	B (Placebo)	Total
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses betamethasone: 12 mg IM q 24 hours x 2 doses	Placebo dose IM q 24 hours x 2 doses placebo: Placebo IM q 24 hours x 2 doses	Total of all reporting groups
Overall Participants	44	41	85
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 100%	41 100%	85 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	26.9 (7.5)	28.6 (6.4)	27.7 (7.0)
Sex: Female, Male (Count of Participants)
Female	44 100%	41 100%	85 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	44 100%	41 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	Measurements of Functional Residual Capacity in Preterm Infants.
Time Frame	Within first 72 hours after birth

Outcome Measure Data

Analysis Population Description

Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.

Arm/Group Title	A (Betamethasone)	B (Placebo)
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	Placebo dose IM q 24 hours x 2 doses
Measure Participants	49	49
Mean (Standard Deviation) [mL/kg]	24.8 (8.8)	22.0 (7.9)

2. Primary Outcome

Title	Measurements of Respiratory Compliance (Crs) in Preterm Infants.
Time Frame	Within first 72 hours after birth

Outcome Measure Data

Analysis Population Description

Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.

Arm/Group Title	A (Betamethasone)	B (Placebo)
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	Placebo dose IM q 24 hours x 2 doses
Measure Participants	49	49
Mean (Standard Deviation) [mL/cm H2O/kg]	1.21 (0.53)	1.01 (0.51)

3. Secondary Outcome

Title	FiO2
Time Frame	During initial hospital stay and planned follow-up

Outcome Measure Data

Analysis Population Description

Number of participants is greater here as it includes all offspring, including twins.

Arm/Group Title	A (Betamethasone)	B (Placebo)
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses	Placebo dose IM q 24 hours x 2 doses
Measure Participants	56	56
FiO2 greater or equal to 0.30	7 15.9%	16 39%
FiO2 greater or equal to 0.40	5 11.4%	13 31.7%

Adverse Events

Adverse Event Reporting Description	Number of participants listed here is greater than the number listed in participant flow as this section includes offspring and twins were included.
Arm/Group Title	A (Betamethasone)		B (Placebo)
Arm/Group Description	Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses		Placebo dose IM q 24 hours x 2 doses
All Cause Mortality
	A (Betamethasone)		B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/56 (1.8%)		0/56 (0%)
Serious Adverse Events
	A (Betamethasone)		B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	A (Betamethasone)		B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.