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Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

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ClinicalTrials.gov Identifier: NCT00669383
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2001
Actual Primary Completion Date : July 2007
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Measurements of Functional Residual Capacity in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]
  2. Measurements of Respiratory Compliance (Crs) in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]

Secondary Outcome Measures :
  1. FiO2 [ Time Frame: During initial hospital stay and planned follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669383


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97219
Sponsors and Collaborators
Oregon Health and Science University
American Lung Association
Investigators
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Principal Investigator: Cynthia McEvoy, MD Oregon Health and Science University
More Information
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Publications of Results:

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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: April 30, 2008    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019
Last Verified: October 2018
Keywords provided by Cynthia McEvoy, Oregon Health and Science University:
premature delivery
respiratory distress syndrome
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents