Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Not Applicable

Completed

• Conditions: Respiratory Compliance; Functional Residual Capacity; Pulmonary Function Testing
• Interventions: Drug: betamethasone; Drug: placebo

• Registration Number: NCT00669383
• Lead Sponsor: Oregon Health and Science University

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.

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 Timeline

• Study Start: 2001-06
• Primary Completion: 2007-07
• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-04-30
• Study Completion: 2009-11
• Status Verified: 2018-10
• Results First Submitted: 2018-10-15
• Results First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Results First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	betamethasone	Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses
B	placebo	Placebo dose intramuscular q 24 hours x 2 doses

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
FiO2	During initial hospital stay and planned follow-up

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States