Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
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|ClinicalTrials.gov Identifier: NCT00139256|
Recruitment Status : Terminated (Slow enrollment and lack of funds.)
First Posted : August 31, 2005
Last Update Posted : November 27, 2013
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%.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Newborn||Drug: Betamethasone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||September 2007|
Placebo Comparator: Placebo
- 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 ]Respiratory distress in the first 24 hours after birth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139256
|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|