N/A
Completed N=85
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
Respiratory Compliance · Functional Residual Capacity · Pulmonary Function Testing
Source: ClinicalTrials.gov NCT00669383 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Measurements of Functional Residual Capacity in Preterm Infants. — 24.8; 22.0 mL/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurements of Functional Residual Capacity in Preterm Infants. |
24.8; 22.0 | — |
| PRIMARY Measurements of Respiratory Compliance (Crs) in Preterm Infants. |
1.21; 1.01 | — |
| SECONDARY FiO2 |
7; 16; 5; 13 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00669383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.