Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

NCT00669383 | Completed Results DMC

• 1 other identifier: OHSU eRIB#1845
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Compliance; Functional Residual Capacity; Pulmonary Function Testing

Keywords

premature delivery; respiratory distress syndrome

Outcome Measures

Primary Outcomes (2)

• Measurements of Functional Residual Capacity in Preterm Infants.

  Within first 72 hours after birth

• Measurements of Respiratory Compliance (Crs) in Preterm Infants.

  Within first 72 hours after birth

Secondary Outcomes (1)

• FiO2

  During initial hospital stay and planned follow-up

Study Arms (2)

A

ACTIVE COMPARATOR

Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses

Drug: betamethasone

B

PLACEBO COMPARATOR

Placebo dose intramuscular q 24 hours x 2 doses

Drug: placebo

Interventions

betamethasone DRUG

12 mg IM q 24 hours x 2 doses

Also known as: Celestone

A

placebo DRUG

Placebo IM q 24 hours x 2 doses

B

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies
• Multiple gestation of triplets or greater
• Mother with insulin dependent diabetes

Sponsors & Collaborators

• Oregon Health and Science University: lead
• American Lung Association: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97219, United States

Location

Related Publications (4)

• 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.

  PMID: 20227053 RESULT

• 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.

  PMID: 28436580 RESULT

• 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.

  PMID: 29795314 RESULT

• 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.

  PMID: 27832835 RESULT

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Cindy McEvoy, MD
• Organization: OHSU

mcevoyc@ohsu.edu

503-494-0223

Study Officials

• Cynthia McEvoy, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: June 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: November 1, 2009
• Last Updated: February 22, 2019
• Results First Posted: February 22, 2019

Record last verified: 2018-10

Locations

US (1)