Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Respiratory Distress Syndrome, Newborn |
Drug: Glucocorticoid (betamethasone) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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.
- The primary endpoint will be the proportion of infants who develop respiratory morbidity.
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | September 2007 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Val Brown, RN, BSN | (404)727-3478 | vdbrown@emory.edu |
| Contact: Golde Dudell, M.D. | (404)727-8682 | gdudell@emory.edu |
| United States, Georgia | |
| Emory University, Department of Pediatrics, Division of Neonatology | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Val Brown, RN, BSN 404-727-3478 vdbrown@emory.edu | |
| Contact: Golde Dudell, M.D. (404)727-8682 gdudell@emory.edu | |
| Sub-Investigator: Golde Dudell, M.D. | |
| Principal Investigator: | Lucky Jain, M.D. | Emory University Department of Pediatrics, Division of Neonatology |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00139256 History of Changes |
| Other Study ID Numbers: | 894-2003 |
| Study First Received: | August 29, 2005 |
| Last Updated: | March 12, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Glucocorticoid Antepartum Betamethasone Treatment Elective Cesarean Section Respiratory Distress in Infants |
Additional relevant MeSH terms:
|
Glucocorticoids Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Betamethasone-17,21-dipropionate Betamethasone |
Betamethasone sodium phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013