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

Study Overview
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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.

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

Conditions
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Preterm Birth

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before SUPPORT<br>01/03-06/05 | |
| During SUPPORT recruitment<br>07/05-02/09 | |
| After SUPPORT<br>03/09-06/10 | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Intratracheal, Continuous Positive Airway Pressure, Historical Cohort Studies, Clinical Trial