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| Sponsored by: |
Emory University |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00139256 |
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: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section |
| 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:
Exclusion Criteria:
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
| Study ID Numbers: | 894-2003 |
| Study First Received: | August 29, 2005 |
| Last Updated: | March 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00139256 |
| Health Authority: | United States: Institutional Review Board |
|
Glucocorticoid Antepartum Betamethasone Treatment Elective Cesarean Section Respiratory Distress in Infants |
|
Betamethasone-17,21-dipropionate Sodium phosphate Respiratory Tract Diseases Betamethasone sodium phosphate Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Newborn Infant, Newborn, Diseases Acute respiratory distress syndrome Infant, Premature, Diseases Betamethasone |
|
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |
