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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

August 29, 2005
November 25, 2013
August 2005
April 2007   (final data collection date for primary outcome measure)
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.
  • 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.
Complete list of historical versions of study NCT00139256 on ClinicalTrials.gov Archive Site
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Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Randomized Controlled Trial of 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%.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Respiratory Distress Syndrome, Newborn
Drug: Betamethasone
Betamethasone injection
  • Experimental: Betamethasone
    Betamethasone injection
    Intervention: Drug: Betamethasone
  • Placebo Comparator: Placebo
    Placebo injection
    Intervention: Drug: Betamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
September 2007
April 2007   (final data collection date for primary outcome measure)

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
Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139256
0894-2003
No
Not Provided
Not Provided
Lucky Jain, Emory University
Emory University
Not Provided
Principal Investigator: Lucky Jain, M.D. Emory University Department of Pediatrics, Division of Neonatology
Emory University
November 2013

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