Status:
COMPLETED
Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation
Lead Sponsor:
Ministry of Health, Sri Lanka
Conditions:
Respiratory Distress of Newborn
Eligibility:
All Genders
20-24 years
Phase:
NA
Brief Summary
The objective of the study is to compare the effectiveness of treatment with Non Invasive Positive Pressure Ventilation (NIPPV) and continuous positive airway pressure (CPAP) in decreasing the require...
Detailed Description
Objective of the study: To compare the effectiveness of CPAP and NIPPV in neonates with mild to moderate respiratory distress. Specific objectives To determine the effectiveness of CPAP and NIPPV in...
Eligibility Criteria
Inclusion
- All neonates with mild to moderate respiratory distress, requiring non invasive respiratory support on admission as defined by one or more of the following
- Respiratory distress needing 3L of O2 to maintain saturation of \>90%
- Silverman Anderson score of 4 - 6
- Apnoea
- \>2 apnoeic attacks needing tactile stimulation for recovery.
- One apnoea needs resuscitation
Exclusion
- Major congenital anomalies
- Presence of cardiovascular instability {sepsis, anemia or severe intraventricular haemorrhage (IVH)}.
- Intubation needed on admission to the NICU
- Consent not provided or refused
- Major cardiac disease (not including patent ductus arteriosus \[PDA\]),
- \-
Key Trial Info
Start Date :
January 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03347136
Start Date
January 10 2015
End Date
December 28 2015
Last Update
November 20 2017
Active Locations (1)
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1
Sri Jayawardanapura teaching hospital
Colombo, Western Province, Sri Lanka, 10100