Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2008

Last Updated Date

January 17, 2012

Start Date ^ICMJE

June 2001

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669383 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Official Title ^ICMJE

Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Respiratory Compliance
Functional Residual Capacity
Pulmonary Function Testing

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Female

Ages

15 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00669383

Other Study ID Numbers ^ICMJE

OHSU eRIB#1845

Has Data Monitoring Committee

Yes

Responsible Party

Cynthia McEvoy, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

American Lung Association

Investigators ^ICMJE

Principal Investigator:

Cynthia McEvoy, MD

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

January 2012

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

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