NCT00669383

Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Compliance
• Functional Residual Capacity
• Pulmonary Function Testing

Interventions

Type	Name	Description
DRUG	betamethasone	12 mg IM q 24 hours x 2 doses
DRUG	placebo	Placebo IM q 24 hours x 2 doses

Timeline

• Start date: 2001-06-01
• Primary completion: 2007-07-01
• Completion: 2009-11-01
• First posted: 2008-04-30
• Last updated: 2019-02-22
• Results posted: 2019-02-22

Locations

1 site across 1 country: United States