Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

October 15, 2018 updated by: Cynthia McEvoy, Oregon Health and Science University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97219
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses
Drug: betamethasone
12 mg IM q 24 hours x 2 doses
Other Names:
  • Celestone
Placebo Comparator: B
Placebo dose intramuscular q 24 hours x 2 doses
Drug: placebo
Placebo IM q 24 hours x 2 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurements of Functional Residual Capacity in Preterm Infants.
Time Frame: Within first 72 hours after birth
Within first 72 hours after birth
Measurements of Respiratory Compliance (Crs) in Preterm Infants.
Time Frame: Within first 72 hours after birth
Within first 72 hours after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
FiO2
Time Frame: During initial hospital stay and planned follow-up
During initial hospital stay and planned follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

American Lung Association

Investigators

  • Principal Investigator: Cynthia McEvoy, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU eRIB#1845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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