Cpap at Delivery Room for Preterm Infants

Phase 4

• Conditions: Mechanical Ventilation; Retinal Disease; Death; Respiratory Tract Disease
• Interventions: Device: CPAP

• Registration Number: NCT01024361
• Lead Sponsor: University of Sao Paulo

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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-11-27
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inborn.

• Birth weight 1000g to 1500g
• No major malformations

Exclusion Criteria

• Necessity of intubation
• Maternal decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP-DR	CPAP	Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life

Primary Outcome Measures

Name	Time	Method
Necessity of mechanical ventilation and surfactant during the first 5 days of life	5 days

Secondary Outcome Measures

Name	Time	Method
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