Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00669383
First received: April 28, 2008
Last updated: January 17, 2012
Last verified: January 2012

April 28, 2008
January 17, 2012
June 2001
July 2007   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00669383 on ClinicalTrials.gov Archive Site
Other respiratory outcomes and clinical outcomes. [ Time Frame: During initial hospital stay and planned follow-up. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Respiratory Compliance
  • Functional Residual Capacity
  • Pulmonary Function Testing
  • Drug: betamethasone
    12 mg IM q 24 hours x 2 doses
    Other Name: Celestone
  • Drug: placebo
    Placebo IM q 24 hours x 2 doses
    Other Name: Placebo
  • Active Comparator: A
    Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
    Intervention: Drug: betamethasone
  • Placebo Comparator: B
    Placebo dose IM q 24 hours x 2 doses
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
July 2007   (final data collection date for primary outcome measure)

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
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669383
OHSU eRIB#1845
Yes
Cynthia McEvoy, Oregon Health and Science University
Oregon Health and Science University
American Lung Association
Principal Investigator: Cynthia McEvoy, MD Oregon Health and Science University
Oregon Health and Science University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP