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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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00308789
Study type Interventional
Source Mount Sinai Hospital, Canada
Contact
Status Terminated
Phase Phase 2
Start date April 2006
Completion date December 2009

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