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Completed

NCT Number: NCT00669383

Rescue Antenatal Steroids and Pulmonary Function Tests 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.

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Key information

Conditions

Respiratory Compliance Female Urogenital Diseases and Pregnancy Complications Functional Residual Capacity Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Function Testing Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone

Drug

12 mg IM q 24 hours x 2 doses

Other names: Celestone

Placebo

Drug

Placebo IM q 24 hours x 2 doses

Primary outcomes

  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 outcomes

  1. FiO2

    Time frame: During initial hospital stay and planned follow-up

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • American Lung Association

Registry information

Official study title

Rescue Antenatal Steroids and Lung Volumes in Preterm Infants

Important dates

Study start
2001
Primary completion
2007
Study completion
2009
First posted
Apr 30, 2008
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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