NCT00308789

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

2.7 years

First QC Date

March 28, 2006

Last Update Submit

May 4, 2009

Conditions

Infant, Premature, DiseasesBronchopulmonary DysplasiaApnea of Prematurity

Keywords

Continuous Positive Airway PressureInfant,newbornArtificial respiration

Outcome Measures

Primary Outcomes (1)

  • The rate of successful extubation with either mode of NCPAP

    Day 7 post primary extubation

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Biphasic NCPAP

Procedure: Biphasic Infant flow NCPAP

2

ACTIVE COMPARATOR

Continuous CPAP

Procedure: CPAP

Interventions

Biphasic Infant flow NCPAPPROCEDURE

Biphasic Nasal continuous positive airway pressure

1
CPAPPROCEDURE

Continuous positive airway pressure

2

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22475409DERIVED

MeSH Terms

Conditions

Infant, Premature, DiseasesBronchopulmonary DysplasiaApnea

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karel O'Brien, MB, FRCPC

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 30, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

CA(1)