Cpap at Delivery Room for Preterm Infants (CPAP-DR)

CPAP Application at Delivery Room at Very Low Birth Weight Infants

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.

Study Overview

• Status: Unknown
• Conditions: Death; Mechanical Ventilation; Respiratory Tract Disease; Retinal Disease
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 15 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:Inborn.

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

Exclusion Criteria:

• Necessity of intubation
• Maternal decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine; Routine protocol of the service
Experimental: CPAP-DR; Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life	Device: CPAP; CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff; Other Names: Neopuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Necessity of mechanical ventilation and surfactant during the first 5 days of life	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	28 days
Oxygen use	56 days
Oxygen use	36 weeks of corrected age
Retinopathies of prematurity	Hospital stay
Death during hospitalization	Hospital stay

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Francisco E Martinez, MD, University of sao Paulo at Ribeirão Preto

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: November 27, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 21, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Newborn; Preterm infants; Nasal CPAP; Delivery room
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Respiratory Tract Diseases
• Other Study ID Numbers: 120789; FAPESP 06/61388-2 (Other Grant/Funding Number: FAPESP 06/61388-2)