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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00308789

Enrollment

136

Registered

2006-03-30

Start date

2006-04-30

Completion date

2009-12-31

Last updated

2009-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity, Bronchopulmonary Dysplasia, Infant, Premature, Diseases

Keywords

Continuous Positive Airway Pressure, Infant,newborn, Artificial respiration

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.

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.

Interventions

PROCEDUREBiphasic Infant flow NCPAP

Biphasic Nasal continuous positive airway pressure

PROCEDURECPAP

Continuous positive airway pressure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The rate of successful extubation with either mode of NCPAP	Day 7 post primary extubation

Secondary

Measure	Time frame
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026