A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams

Phase 2

Terminated

• Conditions: Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Apnea of Prematurity
• Interventions: Procedure: Biphasic Infant flow NCPAP; Procedure: CPAP

• Registration Number: NCT00308789
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage.

Detailed Description

Chronic lung disease (CLD) remains a significant problem among low birth weight infants with a reported incidence of up to 26% in infants \< 1500 grams. Nasal continuous positive airway pressure (NCPAP) has been demonstrated to provide effective non-invasive respiratory support for preterm infants. The use of NCPAP is associated with a decreased need for mechanical ventilation and may impact on the incidence of CLD. There are two types of NCPAP now available, a Biphasic mode which allows for cycling at two different levels of positive pressure and a continuous mode which allows only for one level of positive pressure.

Comparisons: Biphasic NCPAP will be compared with continuous CPAP to see which better facilitates the extubation of preterm infants who weigh \</= 1250 grams at birth. The incidence of CLD, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and necrotizing entercolitis will also be compared between the two groups.

Study Timeline

• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-30
• Study Start: 2006-04
• Primary Completion: 2008-12
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-04
• Last Update Posted: 2009-05-05
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Infants </= 1250 grams who are going to be extubated

Exclusion Criteria

• Congenital abnormalities of the upper airway
• Acquired nasal septum injury
• Congenital Heart Disease excluding Patent Ductus arteriosus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Biphasic Infant flow NCPAP	Biphasic NCPAP
2	CPAP	Continuous CPAP

Primary Outcome Measures

Name	Time	Method
The rate of successful extubation with either mode of NCPAP	Day 7 post primary extubation

Secondary Outcome Measures

Name	Time	Method
The incidence of chronic lung disease
The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
The predictive value of the minute ventilation test

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada