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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308789
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 30, 2006
Last Update Posted : May 5, 2009
The Physicians' Services Incorporated Foundation
Information provided by:
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2006
Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The rate of successful extubation with either mode of NCPAP [ Time Frame: Day 7 post primary extubation ]

Secondary Outcome Measures :
  1. The incidence of chronic lung disease
  2. The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
  3. The predictive value of the minute ventilation test

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308789

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00308789     History of Changes
Other Study ID Numbers: 05-0258-A
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Mount Sinai Hospital, Canada:
Continuous Positive Airway Pressure
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