Antepartum Betamethasone Treatment for Prevention of Resp... | NCT00139256

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

NCT00139256

Sponsor

Emory University

Status

Terminated

Last Update Posted

Nov 27, 2013Estimated

Enrollment

67Actual

Phase

Phase 2Phase 3

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Betamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment and lack of funds.

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Apr 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2013

Last Update Posted Date

Nov 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Betamethasone	Experimental	Betamethasone injection	Drug: Betamethasone
Placebo	Placebo Comparator	Placebo injection	Drug: Betamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betamethasone	Drug	Betamethasone injection	Betamethasone Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.	Respiratory distress in the first 24 hours after birth.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucky Jain, M.D.	Emory University Department of Pediatrics, Division of Neonatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University affiliated newborn intensive care units		Atlanta	Georgia	30322	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34935127	Derived	Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids