Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial

NCT ID: NCT01601886

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-04-30

Brief Summary

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This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.

The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.

Detailed Description

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Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Before SUPPORT

01/03-06/05

No interventions assigned to this group

During SUPPORT recruitment

07/05-02/09

No interventions assigned to this group

After SUPPORT

03/09-06/10

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010

Exclusion Criteria

* Infants receiving comfort care
* Those with major congenital anomalies
* Those enrolled in the SUPPORT trial
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Luc Brion

OTHER

Sponsor Role lead

Responsible Party

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Luc Brion

Professor of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luc P Brion, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Southwestern

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Velos 12121

Identifier Type: OTHER

Identifier Source: secondary_id

STU 092010-201

Identifier Type: -

Identifier Source: org_study_id

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