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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth

• Study Type: Observational
• Enrollment (Actual): 3843

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9063
      • University of Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Before SUPPORT; 01/03-06/05
During SUPPORT recruitment; 07/05-02/09
After SUPPORT; 03/09-06/10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotracheal intubation in the delivery room	Frequency of endotracheal intubation in the delivery room	In the delivery room (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous positive airway pressure in the delivery room	Frequency of continuous positive airway pressure in the delivery room	In the delivery room (1 day)
Endotracheal intubation in the first four hours after admission	Frequency of endotracheal intubation in the first fours after admission to the neonatal intensive care unit	First four hours after admission
Endotracheal intubation until four hours after admission	Frequency of endotracheal intubation between birth and four hours after admission in the neonatal intensive care unit	Between birth and 4 hours after admission
Admninistration of surfactant	Frequency of admninistration of surfactant any time between birth and 2 days of age	Any time between birth and 2 days of age
Pneumothorax	Pneumothorax any time before discharge or transfer or 12 months of age (whichever comes first)	Any time before discharge or transfer or 12 months of age (whichever comes first)
Bronchopulmonary dysplasia	Chronic changes on chest radiograph and oxygen requirement (fractional inspiratory concentration of oxygen greater than 0.21) for at least 28 days	28 days
Necrotizing enterocolitis	Necrotizing enterocolitis (at least stage II, modified Bell's classification) any time before discharge or transfer or 12 months of age (whichever comes first)	Any time before discharge or transfer or 12 months of age (whichever comes first)
Duration of mechanical ventilation	Duration of invasive mechanical ventilation until discharge or transfer or or 12 months of age (whichever comes first)	Until discharge or transfer or 12 months of age (whichever comes first)
Maximum oxygen concentration	Maximum inspiratory oxygen concentration until discharge or transfer or 12 months of age (whichever comes first)	Until discharge or transfer or 12 months of age (whichever comes first)
Severe retinopathy of prematurity	Severe retinopathy of prematurity (at least stage III, international classification) until discharge or transfer or 12 months of age (whichever comes first)	Until discharge or transfer or 12 months of age (whichever comes first)
Mortality	Mortality until discharge or transfer or 12 months of age (whichever comes first)	Until discharge or transfer or 12 months of age (whichever comes first)
Severe brain lesion on imaging	Cystic periventricular leukomalacia or grade III or IV intraventricular/ periventricular hemorrhage detected by ultrasonogram any time before discharge or transfer or 12 months of age (whichever comes first)	Any time before discharge or transfer or 12 months of age (whichever comes first)

Collaborators and Investigators

• Sponsor: Luc Brion
• Collaborators: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Luc P Brion, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 18, 2012
• Last Update Submitted That Met QC Criteria: May 17, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Clinical Trial; Intubation, Intratracheal; Historical Cohort Studies
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: STU 092010-201; Velos 12121 (Other Identifier: University of Texas Southwestern)