Official Title: “Rescue Antenatal Steroids and Lung Volumes in Preterm Infants”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: betamethasone
  • 12 mg IM q 24 hours x 2 doses
• Drug: placebo
  • Placebo IM q 24 hours x 2 doses

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
• Placebo Comparator: B
  • Placebo dose IM q 24 hours x 2 doses

Primary Measures

• Measurements of respiratory compliance and functional residual capacity in preterm infants.
  • Time Frame: Measurements are done within first 72 hours with planned follow-up testing.
    Safety Issue?: No

Secondary Measures

• Other respiratory outcomes and clinical outcomes.
  • Time Frame: During initial hospital stay and planned follow-up.
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Cynthia McEvoy, MD Principal Investigator Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669383

Study ID Number: OHSU eRIB#1845

ClinicalTrials.gov Identifier: NCT00669383

Health Authority: United States: Institutional Review Board