Efficacy of Surfactant administration through Laryngeal Mask Airway (LMA) vs Less Invasive Surfactant Administration (LISA) in Preterm Neonates.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Need for mechanical ventilation within 72 hours of surfactant administration
Study Overview
Brief Summary
Eligible preterm neonates will be randomized in two groups. Group 1 (LMA group) and Group 2 (LISA group) and allocation ratio will be kept in 1 is to 1 ratio. Before the procedure interface will be changed to snugly fitting nasal cannula for delivering Non- Invasive Positive Pressure Ventilation (NIPPV) and will be reinstituted prior NIPPV after completion of the procedure. Surfactant will be administered through LMA in group 1 and through LISA in group 2. Both groups will have the same pre-specified criteria for surfactant re-dosing. If FiO2 equal to 20 percent higher than the baseline FiO2 within 8 h of therapy, surfactant will be re-dosed in either group, after excluding other causes of respiratory insufficiency. Beyond 8 h of the First dose, re-dosing will be considered if FiO2 greater than or equal to 0.60 or if FiO2 greater than or equal to 0.30, associated with worsening clinical signs of RDS. Neonates will be then observed for parameters like need for Mechanical Ventilation, Transient Bradycardia or Desaturation, IVH, NEC, Duration of Hospital stay and Mortality and the data will be recorded. Neonates will be followed up till their discharge from the hospital or till the secondary outcome. All data will be analysed using suitable statistical methods and p-value less than 0.05 will be considered the cut off value for significance in all analysis involved.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Preterm infants between 30 to 34+6 weeks of gestation who develop mild to moderate respiratory distress between 4 to 48 hours of birth, requiring FiO2 0.3 to 0.60 to maintain SpO2 88 to 95 percent on nCPAP of 5to 6 cm of H2O and signed the parental consent.
Exclusion Criteria
- •Previous intubation or Surfactant therapy.
- •Apgar score of greater than or equal to 3 at 5 min.
- •Pneumothorax prior to enrolment.
- •Severe RDS indicated by FiO2 greater than 0.
- •Newborns with major congenital anomalies (major malformations involving craniofacial, Cardiac or thoracic).
- •Newborns with perinatal asphyxia.
Outcomes
Primary Outcomes
Need for mechanical ventilation within 72 hours of surfactant administration
Time Frame: Within 3 Days
Secondary Outcomes
- Duration of hospital stay(Intraventricular haemorrhage (IVH))
Investigators
Kapil Bhalla
Pt. Bhagwat Dayal Sharma Institute of health sciences.