Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Distress Syndrome, Newborn
Intervention: Betamethasone (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Lucky Jain, M.D., Principal Investigator, Affiliation: Emory University Department of Pediatrics, Division of Neonatology
Summary
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone
versus a placebo given prior to the mothers at term and near term gestation (>34 and <40
weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study
design is to determine the efficacy and safety of betamethasone in the prevention of
breathing problems commonly seen in this population.
In infants born by elective Cesarean section, it is hypothesized that antenatal
betamethasone treatment will reduce the risk of neonatal intensive care unit (NICU)
admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for
>30 minutes from 4. 5% to 2. 5%.
Clinical Details
Official title: Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.
Detailed description:
The purpose of this pilot study is to determine if antepartum betamethasone given to mothers
undergoing elective cesarean section (ECS) delivery at term or near term gestation (>34 and
< 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and
the related admissions to neonatal intensive care units (NICU).
The data from this pilot study will be used to support a NIH application for a multicenter
randomized trial to determine, if compared to placebo treatment, antenatal betamethasone
initiated 2-7 days prior to an ECS results in decreased occurrence of respiratory morbidity
and NICU admissions in the newborn.
The multicenter protocol was recently reviewed by the NICHD network for clinical trial. The
reviewers were enthusiastic about the scientific merit and public health importance of the
study but asked for a pilot study to determine feasibility before launching the national
trial. Given the rise in the rate of CS deliveries, we project substantial health cost
savings from this preventive strategy if it were found to be successful in reducing neonatal
morbidity.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant women >/= 34 weeks gestation scheduled to undergo operative delivery within
48-72 hours after study enrollment
Exclusion Criteria:
- Known contraindication to the use of betamethasone in the mother
- Known lethal or non-lethal congenital anomaly diagnosed antenatally
- Spontaneous labor
- Premature rupture of membranes
Locations and Contacts
Emory University affiliated newborn intensive care units, Atlanta, Georgia 30322, United States
Additional Information
Starting date: August 2005
Last updated: November 25, 2013
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