Clinical trial NCT00669383: Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
Official title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Compliance
Functional Residual Capacity
Pulmonary Function Testing
Keywords: premature delivery
respiratory distress syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2008-04-30
Enrollment: 85
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Measurements of Functional Residual Capacity in Preterm Infants.
timeFrame: Within first 72 hours after birth
measure: Measurements of Respiratory Compliance (Crs) in Preterm Infants.
timeFrame: Within first 72 hours after birth
Secondary outcomes:
measure: FiO2
timeFrame: During initial hospital stay and planned follow-up
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Cynthia McEvoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2010 Jun;202(6):544.e1-9. doi: 10.1016/j.ajog.2010.01.038. Epub 2010 Mar 15.
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.
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.
citation: 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.