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

Primary Purpose

Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Biphasic Infant flow NCPAP
CPAP
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring Continuous Positive Airway Pressure, Infant,newborn, Artificial respiration

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Biphasic NCPAP

Continuous CPAP

Outcomes

Primary Outcome Measures

The rate of successful extubation with either mode of NCPAP

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2006
Last Updated
May 4, 2009
Sponsor
Mount Sinai Hospital, Canada
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00308789
Brief Title
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
Official Title
Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity
Keywords
Continuous Positive Airway Pressure, Infant,newborn, Artificial respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Biphasic NCPAP
Arm Title
2
Arm Type
Active Comparator
Arm Description
Continuous CPAP
Intervention Type
Procedure
Intervention Name(s)
Biphasic Infant flow NCPAP
Intervention Description
Biphasic Nasal continuous positive airway pressure
Intervention Type
Procedure
Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure
Primary Outcome Measure Information:
Title
The rate of successful extubation with either mode of NCPAP
Time Frame
Day 7 post primary extubation
Secondary Outcome Measure Information:
Title
The incidence of chronic lung disease
Title
The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
Title
The predictive value of the minute ventilation test

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel O'Brien, MB, FRCPC
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22475409
Citation
O'Brien K, Campbell C, Brown L, Wenger L, Shah V. Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' </= 1,250 grams: a randomized controlled trial. BMC Pediatr. 2012 Apr 4;12:43. doi: 10.1186/1471-2431-12-43.
Results Reference
derived

Learn more about this trial

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

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