Preterm Birth
Conditions
Keywords
Intubation, Intratracheal, Continuous Positive Airway Pressure, Historical Cohort Studies, Clinical Trial
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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Luc Brion
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 35 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal intubation in the delivery room | In the delivery room (1 day) | Frequency of endotracheal intubation in the delivery room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal intubation in the first four hours after admission | First four hours after admission | Frequency of endotracheal intubation in the first fours after admission to the neonatal intensive care unit |
| Endotracheal intubation until four hours after admission | Between birth and 4 hours after admission | Frequency of endotracheal intubation between birth and four hours after admission in the neonatal intensive care unit |
| Admninistration of surfactant | Any time between birth and 2 days of age | Frequency of 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) | Pneumothorax any time before discharge or transfer or 12 months of age (whichever comes first) |
| Bronchopulmonary dysplasia | 28 days | Chronic changes on chest radiograph and oxygen requirement (fractional inspiratory concentration of oxygen greater than 0.21) for at least 28 days |
| Continuous positive airway pressure in the delivery room | In the delivery room (1 day) | Frequency of continuous positive airway pressure in the delivery room |
| Duration of mechanical ventilation | Until discharge or transfer or 12 months of age (whichever comes first) | Duration of invasive mechanical ventilation until discharge or transfer or or 12 months of age (whichever comes first) |
| Maximum oxygen concentration | Until discharge or transfer or 12 months of age (whichever comes first) | Maximum inspiratory oxygen concentration until discharge or transfer or 12 months of age (whichever comes first) |
| Severe retinopathy of prematurity | Until discharge or transfer or 12 months of age (whichever comes first) | Severe retinopathy of prematurity (at least stage III, international classification) until discharge or transfer or 12 months of age (whichever comes first) |
| Mortality | Until discharge or transfer or 12 months of age (whichever comes first) | Mortality until discharge or transfer or 12 months of age (whichever comes first) |
| Severe brain lesion on imaging | Any time before discharge or transfer or 12 months of age (whichever comes first) | 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) |
| Necrotizing enterocolitis | Any time before discharge or transfer or 12 months of age (whichever comes first) | Necrotizing enterocolitis (at least stage II, modified Bell's classification) any time before discharge or transfer or 12 months of age (whichever comes first) |
Countries
United States
Outcome results
None listed