Clinical efficacy of synchronized nasal intermittent positive pressure ventilation versus high continuous positive airway pressure as primary mode of respiratory support in preterm neonates(28-34weeks): a randomized controlled trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IPGME&R and SSKM Hospital
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
Overview
Brief Summary
This study is a randomized controlled trial comparing the clinical efficacy of two non-invasive ventilation methods—Synchronized Nasal Intermittent Positive Pressure Ventilation (NIPPV) and High Continuous Positive Airway Pressure (CPAP)—in preterm neonates (28-34 weeks). The trial aims to determine which method is more effective as the primary mode of respiratory support for neonates experiencing respiratory distress.
Key objectives include:
- Primary Objective: Assess the need for intubation within 72 hours of starting the assigned mode.
- Secondary Objectives: Examine other clinical outcomes such as the duration of respiratory support, feeding tolerance, the occurrence of necrotizing enterocolitis (NEC), pulmonary air leaks, and length of stay in the neonatal intensive care unit (NICU).
The study will be conducted at IPGMER & SSKM Hospital in Kolkata and will involve 108 participants, randomly assigned to one of the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Day(s) to 3.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All Intramural Preterm (28 to 34 weeks GA) neonate within 72 hrs of life with respiratory distress.
Exclusion Criteria
- •Major Congenital anomalies Suspected Chromosomal anomalies Requirement of Vasopressor/ mechanical ventilation/ hemodynamically unstable at the time of randomisation Severe Perinatal asphyxia Upper airway anomalies Outborn neonates.
Outcomes
Primary Outcomes
Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
Time Frame: Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support
Secondary Outcomes
- Duration of respiratory support(At 4 weeks)
- Requirement of intravenous fluid before reaching full feeds(At 2 weeks)
- Incidence of feed intolerance(At 4 weeks)
- Incidence of NEC(At 4 weeks)
- Incidence of pulmonary air leak(At 4 weeks)
- Incidence of IVH(At 4 weeks)
- Incidence of culture positive sepsis(At 4 weeks)
- Incidence of BPD(At 4 weeks)
- Incidence of hsPDA requiring treatment(At 4 weeks)
- Incidence of ROP(At 4 weeks)
- Length of NICU stay(At 4 weeks)
Investigators
Madhurima Ganguly
Institute of Post Graduate Medical Education and Research,Kolkata