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

NCT ID: NCT00308789

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Infant, Premature, Diseases Bronchopulmonary Dysplasia Apnea of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Biphasic NCPAP

Group Type EXPERIMENTAL

Biphasic Infant flow NCPAP

Intervention Type PROCEDURE

Biphasic Nasal continuous positive airway pressure

2

Continuous CPAP

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type PROCEDURE

Continuous positive airway pressure

Interventions

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Biphasic Infant flow NCPAP

Biphasic Nasal continuous positive airway pressure

Intervention Type PROCEDURE

CPAP

Continuous positive airway pressure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Principal Investigators

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Karel O'Brien, MB, FRCPC

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 22475409 (View on PubMed)

Other Identifiers

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05-0258-A

Identifier Type: -

Identifier Source: org_study_id

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