CPAP Application at Delivery Room at Very Low Birth Weight Infants
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation
- Sponsor
- University of Sao Paulo
- Enrollment
- 200
- Primary Endpoint
- Necessity of mechanical ventilation and surfactant during the first 5 days of life
- Last Updated
- 16 years ago
Overview
Brief Summary
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
Detailed Description
A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs
Investigators
Eligibility Criteria
Inclusion Criteria
- •Birth weight 1000g to 1500g
- •No major malformations
Exclusion Criteria
- •Necessity of intubation
- •Maternal decision
Outcomes
Primary Outcomes
Necessity of mechanical ventilation and surfactant during the first 5 days of life
Time Frame: 5 days
Secondary Outcomes
- Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life(15 minutes)
- Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis(30 days)
- Oxygen use(36 weeks of corrected age)
- Retinopathies of prematurity(Hospital stay)
- Death during hospitalization(Hospital stay)