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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00308789
• Other study ID #: 05-0258-A
• Status: Terminated
• Phase: Phase 2
• First received: March 28, 2006
• Last updated: May 4, 2009
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biphasic Infant flow NCPAP
Biphasic Nasal continuous positive airway pressure
• CPAP
Continuous positive airway pressure

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful extubation with either mode of NCPAP		Day 7 post primary extubation	Yes
Secondary	The incidence of chronic lung disease
Secondary	The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
Secondary	The predictive value of the minute ventilation test