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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601886
• Other study ID #: STU 092010-201
• Secondary ID: Velos 12121
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: May 17, 2012
• Start date: April 2008
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3843
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 35 Weeks

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Luc Brion	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotracheal intubation in the delivery room	Frequency of endotracheal intubation in the delivery room	In the delivery room (1 day)	No
Secondary	Continuous positive airway pressure in the delivery room	Frequency of continuous positive airway pressure in the delivery room	In the delivery room (1 day)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No