- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669383
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
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
-
-
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
|
12 mg IM q 24 hours x 2 doses
Other Names:
|
Placebo Comparator: B
Placebo dose intramuscular q 24 hours x 2 doses
|
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.
Collaborators
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
- McEvoy C, Schilling D, Peters D, Tillotson C, Spitale P, Wallen L, Segel S, Bowling S, Gravett M, Durand M. Respiratory compliance in preterm infants after a single rescue course of antenatal steroids: a randomized controlled trial. Am J Obstet Gynecol. 2010 Jun;202(6):544.e1-9. doi: 10.1016/j.ajog.2010.01.038. Epub 2010 Mar 15.
- McEvoy C, Schilling D, Spitale P, O'Malley J, Bowling S, Durand M. Pulmonary function and outcomes in infants randomized to a rescue course of antenatal steroids. Pediatr Pulmonol. 2017 Sep;52(9):1171-1178. doi: 10.1002/ppul.23711. Epub 2017 Apr 24.
- Jordan BK, Schilling D, McEvoy CT. The window of improved neonatal respiratory compliance after rescue antenatal steroids. J Perinatol. 2018 Jul;38(7):828-833. doi: 10.1038/s41372-018-0124-9. Epub 2018 May 24.
- Jordan BK, Schilling D, McEvoy CT. Pulmonary Function at Hospital Discharge in Preterm Infants Randomized to a Single Rescue Course of Antenatal Steroids. J Pediatr. 2017 Feb;181:62-66.e1. doi: 10.1016/j.jpeds.2016.10.022. Epub 2016 Nov 7.
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
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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