Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

NCT01206946

Respiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn

UNKNOWN PHASE2

Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

NCT00000563

Lung Diseases Respiratory Distress Syndrome

COMPLETED PHASE3

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

NCT01222247

Pregnancy Respiratory Distress Syndrome Pregnancy Outcomes +1 more

COMPLETED PHASE3

Antenatal Corticoid Therapy for Late Preterm Babies

NCT00675246

Hyaline Membrane Disease Transient Tachypnea

COMPLETED NA

Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth

NCT02793700

Premature Labor

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Compliance Functional Residual Capacity Pulmonary Function Testing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type ACTIVE_COMPARATOR

betamethasone

Intervention Type DRUG

12 mg IM q 24 hours x 2 doses

B

Placebo dose intramuscular q 24 hours x 2 doses

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo IM q 24 hours x 2 doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

betamethasone

12 mg IM q 24 hours x 2 doses

Intervention Type DRUG

placebo

Placebo IM q 24 hours x 2 doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Celestone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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