Clinical trial NCT01601886: Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial
Official title: Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Intubation, Intratracheal
Continuous Positive Airway Pressure
Historical Cohort Studies
Clinical Trial
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2012-05-18
Enrollment: 3843
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endotracheal intubation in the delivery room
timeFrame: In the delivery room (1 day)
Secondary outcomes:
measure: Continuous positive airway pressure in the delivery room
timeFrame: In the delivery room (1 day)
measure: Endotracheal intubation in the first four hours after admission
timeFrame: First four hours after admission
measure: Endotracheal intubation until four hours after admission
timeFrame: Between birth and 4 hours after admission
measure: Admninistration of surfactant
timeFrame: Any time between birth and 2 days of age
measure: Pneumothorax
timeFrame: Any time before discharge or transfer or 12 months of age (whichever comes first)
measure: Bronchopulmonary dysplasia
timeFrame: 28 days
measure: Necrotizing enterocolitis
timeFrame: Any time before discharge or transfer or 12 months of age (whichever comes first)
measure: Duration of mechanical ventilation
timeFrame: Until discharge or transfer or 12 months of age (whichever comes first)
measure: Maximum oxygen concentration
timeFrame: Until discharge or transfer or 12 months of age (whichever comes first)
measure: Severe retinopathy of prematurity
timeFrame: Until discharge or transfer or 12 months of age (whichever comes first)
measure: Mortality
timeFrame: Until discharge or transfer or 12 months of age (whichever comes first)
measure: Severe brain lesion on imaging
timeFrame: Any time before discharge or transfer or 12 months of age (whichever comes first)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Texas
name: Luc P Brion, MD
role: PRINCIPAL_INVESTIGATOR
References: