NCT01024361

Cpap at Delivery Room for Preterm Infants

CPAP Application at Delivery Room at Very Low Birth Weight Infants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 1 Minute – 15 Minutes
• Healthy volunteers: Not accepted

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

Conditions

• Mechanical Ventilation
• Retinal Disease
• Death
• Respiratory Tract Disease

Interventions

Type	Name	Description
DEVICE	CPAP	CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2009-12-02
• Last updated: 2009-12-23