Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section

Tracking Information
First Submitted Date ICMJE	August 29, 2005
First Posted Date ICMJE	August 31, 2005
Last Update Posted Date	November 27, 2013
Study Start Date ICMJE	August 2005
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 25, 2013)	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.
Original Primary Outcome Measures ICMJE; (submitted: August 30, 2005)	The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.; The primary endpoint will be the proportion of infants who develop respiratory morbidity.
Change History	Complete list of historical versions of study NCT00139256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Official Title ICMJE	Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Brief 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%.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Respiratory Distress Syndrome, Newborn
Intervention ICMJE	Drug: Betamethasone; Betamethasone injection
Study Arms	Experimental: Betamethasone Betamethasone injection Intervention: Drug: Betamethasone; Placebo Comparator: Placebo Placebo injection Intervention: Drug: Betamethasone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: November 25, 2013)	67
Original Enrollment ICMJE; (submitted: August 30, 2005)	400
Actual Study Completion Date	September 2007
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00139256
Other Study ID Numbers ICMJE	0894-2003
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lucky Jain, Emory University
Study Sponsor ICMJE	Emory University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Lucky Jain, M.D. Emory University Department of Pediatrics, Division of Neonatology
PRS Account	Emory University
Verification Date	November 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP