Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139256
Status:
TERMINATED
Last Update Posted:
2013-11-27
First Post:
2005-08-29
Brief Title:
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment and lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor oxygen therapy - positive pressure ventilation PPV for 30 minutes from 45 to 25
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 andor oxygen therapy - positive pressure ventilation PPV for 30 minutes from 45 to 25
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None