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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

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status and phase

Terminated
Phase 2

Conditions

Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Apnea of Prematurity

Treatments

Procedure: CPAP
Procedure: Biphasic Infant flow NCPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT00308789
05-0258-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

Under 6 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

1
Experimental group
Description:
Biphasic NCPAP
Treatment:
Procedure: Biphasic Infant flow NCPAP
2
Active Comparator group
Description:
Continuous CPAP
Treatment:
Procedure: CPAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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