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

NCT01601886 | Completed

• 2 other identifiers: STU 092010-201Velos 12121
• Study Type: observational
• Target: 3,843
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth

Keywords

Intubation, Intratracheal; Continuous Positive Airway Pressure; Historical Cohort Studies; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation in the delivery room

  Frequency of endotracheal intubation in the delivery room

  In the delivery room (1 day)

Secondary Outcomes (12)

• Continuous positive airway pressure in the delivery room

  In the delivery room (1 day)

• Endotracheal intubation in the first four hours after admission

  First four hours after admission

• Endotracheal intubation until four hours after admission

  Between birth and 4 hours after admission

• Admninistration of surfactant

  Any time between birth and 2 days of age

• Pneumothorax

  Any time before discharge or transfer or 12 months of age (whichever comes first)

Study Arms (3)

Before SUPPORT

01/03-06/05

During SUPPORT recruitment

07/05-02/09

After SUPPORT

03/09-06/10

Eligibility Criteria

• Age: 24 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Infants receiving comfort care
• Those with major congenital anomalies
• Those enrolled in the SUPPORT trial

Sponsors & Collaborators

• Luc Brion: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390-9063, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Luc P Brion, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

US (1)