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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

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00308789
First received: March 28, 2006
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Apnea of Prematurity
 Procedure: Biphasic Infant flow NCPAP
Procedure: CPAP
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • The rate of successful extubation with either mode of NCPAP [ Time Frame: Day 7 post primary extubation ] [ Designated as safety issue: Yes ]

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

Enrollment: 136
Study Start Date: April 2006
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Biphasic NCPAP
 Procedure: Biphasic Infant flow NCPAP
Biphasic Nasal continuous positive airway pressure
Active Comparator: 2
Continuous CPAP
 Procedure: CPAP
Continuous positive airway pressure

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308789

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Karel O'Brien, MB, FRCPC Mount Sinai Hospital, New York
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00308789     History of Changes
Other Study ID Numbers: 05-0258-A
Study First Received: March 28, 2006
Last Updated: May 4, 2009
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Continuous Positive Airway Pressure
Infant,newborn
Artificial respiration

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Infant, Premature, Diseases
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013