Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
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%.
Respiratory Distress Syndrome, Newborn
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section|
- The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Respiratory distress in the first 24 hours after birth.
|Study Start Date:||August 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
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.
|United States, Georgia|
|Emory University affiliated newborn intensive care units|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Lucky Jain, M.D.||Emory University Department of Pediatrics, Division of Neonatology|