Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Functional Residual Capacity Clinical Trial

Official title:

Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669383
• Other study ID #: OHSU eRIB#1845
• Status: Completed
• Phase: N/A
• Start date: June 2001
• Est. completion date: November 2009

Study information

• Verified date: October 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Residual Capacity
• Pulmonary Function Testing
• Respiratory Compliance

Intervention

Drug:
• betamethasone
12 mg IM q 24 hours x 2 doses
• placebo
Placebo IM q 24 hours x 2 doses

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	American Lung Association

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of Functional Residual Capacity in Preterm Infants.		Within first 72 hours after birth
Primary	Measurements of Respiratory Compliance (Crs) in Preterm Infants.		Within first 72 hours after birth
Secondary	FiO2		During initial hospital stay and planned follow-up