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Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

NCT00669383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2019-02-22

Study results available
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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.

Conditions

  • Respiratory Compliance
  • Functional Residual Capacity
  • Pulmonary Function Testing

Interventions

DRUG

betamethasone

12 mg IM q 24 hours x 2 doses

DRUG

placebo

Placebo IM q 24 hours x 2 doses

Sponsors & Collaborators

  • American Lung Association

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Cynthia McEvoy, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2007-07-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669383 on ClinicalTrials.gov