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
  Purpose

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.


Condition Intervention
Respiratory Compliance
Functional Residual Capacity
Pulmonary Function Testing
Drug: betamethasone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other respiratory outcomes and clinical outcomes. [ Time Frame: During initial hospital stay and planned follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
Drug: betamethasone
12 mg IM q 24 hours x 2 doses
Other Name: Celestone
Placebo Comparator: B
Placebo dose IM q 24 hours x 2 doses
Drug: placebo
Placebo IM q 24 hours x 2 doses
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669383

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97219
Sponsors and Collaborators
Oregon Health and Science University
American Lung Association
Investigators
Principal Investigator: Cynthia McEvoy, MD Oregon Health and Science University
  More Information

Publications:
Responsible Party: Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00669383     History of Changes
Other Study ID Numbers: OHSU eRIB#1845
Study First Received: April 28, 2008
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
premature delivery
respiratory distress syndrome

Additional relevant MeSH terms:
Betamethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 16, 2014