Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

Conditions
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Respiratory Compliance, Functional Residual Capacity, Pulmonary Function Testing

Intervention / Treatment
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* Drug: betamethasone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses | Drug: betamethasone<br>* 12 mg IM q 24 hours x 2 doses<br>* Other names: Celestone;|
| Placebo Comparator: B<br>Placebo dose intramuscular q 24 hours x 2 doses | Drug: placebo<br>* Placebo IM q 24 hours x 2 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of Functional Residual Capacity in Preterm Infants. |  | Within first 72 hours after birth | 
| Measurements of Respiratory Compliance (Crs) in Preterm Infants. |  | Within first 72 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FiO2 |  | During initial hospital stay and planned follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature delivery, respiratory distress syndrome