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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

March 28, 2006
May 4, 2009
April 2006
December 2008   (final data collection date for primary outcome measure)
The rate of successful extubation with either mode of NCPAP [ Time Frame: Day 7 post primary extubation ] [ Designated as safety issue: Yes ]
The rate of successful extubation with either mode of NCPAP
Complete list of historical versions of study NCT00308789 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infant, Premature, Diseases
  • Bronchopulmonary Dysplasia
  • Apnea of Prematurity
  • Procedure: Biphasic Infant flow NCPAP
    Biphasic Nasal continuous positive airway pressure
  • Procedure: CPAP
    Continuous positive airway pressure
  • Experimental: 1
    Biphasic NCPAP
    Intervention: Procedure: Biphasic Infant flow NCPAP
  • Active Comparator: 2
    Continuous CPAP
    Intervention: Procedure: CPAP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00308789
05-0258-A
No
Not Provided
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Principal Investigator: Karel O'Brien, MB, FRCPC Mount Sinai Hospital, New York
Mount Sinai Hospital, Canada
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP