Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

• ClinicalTrials.gov Identifier: NCT00669383
• Recruitment Status: Completed
• First Posted: April 30, 2008
• Results First Posted: February 22, 2019
• Last Update Posted: February 22, 2019
• Sponsor: Oregon Health and Science University
• Collaborator: American Lung Association
• Information provided by (Responsible Party): Cynthia McEvoy, Oregon Health and Science University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Compliance; Functional Residual Capacity; Pulmonary Function Testing	Drug: betamethasone; Drug: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
• Study Start Date: June 2001
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: November 2009

Arms and Interventions

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 Name: Celestone
Placebo Comparator: B; Placebo dose intramuscular q 24 hours x 2 doses	Drug: placebo; Placebo IM q 24 hours x 2 doses

Outcome Measures

Primary Outcome Measures :

1. Measurements of Functional Residual Capacity in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]
2. Measurements of Respiratory Compliance (Crs) in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]

Secondary Outcome Measures :

1. FiO2 [ Time Frame: During initial hospital stay and planned follow-up ]

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes 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

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 of Results:

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.

• 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
• First Posted: April 30, 2008
• Results First Posted: February 22, 2019
• Last Update Posted: February 22, 2019
• Last Verified: October 2018

Keywords provided by Cynthia McEvoy, Oregon Health and Science University:

premature delivery; respiratory distress syndrome

Additional relevant MeSH terms:

Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents