Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Infant, Premature, Diseases
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- The rate of successful extubation with either mode of NCPAP
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The rate of successful extubation with either mode of NCPAP
Time Frame: Day 7 post primary extubation
Secondary Outcomes
- 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