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

This study has been terminated.

(Slow enrollment and lack of funds.)

Sponsor:

Information provided by (Responsible Party):

Lucky Jain, Emory University

ClinicalTrials.gov Identifier:

NCT00139256

First received: August 29, 2005

Last updated: November 25, 2013

Last verified: November 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

November 25, 2013

Start Date ^ICMJE

August 2005

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Respiratory Distress Syndrome, Newborn

Intervention ^ICMJE

Drug: Betamethasone

Betamethasone injection

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

September 2007

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

Gender

Female

Ages

Not Provided

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

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

Information Provided By

Emory University

Verification Date

November 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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