Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Bovine surfactant(Survanta/Neosurf) administration by LISA method: Preterm infants less than or equal to 30 weeks with features of respiratory distress syndrome will be given bovine sur
repeat doses are given as per manufacturer recommendations which are maximum upto 3 repeat doses(repeat dose given after 6 hours of previous dose)
dose of repeat course is same as 1st dose.
The dose of Neosurf is 135 mg/kg (5ml/kg) given via intratracheal route with the use of a thin catheter
repeat doses are as per manufacturer recommendations which are maximum upto 2 repeat doses (repeat dose given after 6 hours of previous dose)
dose of repeat course is same as 1st dose.
Intervention2: Porcine surfactant(Poractant alfa) administration by LISA method: Preterm infants less than or equal to 30 weeks with features of respiratory
repeat doses are given as per manufacturer recommendations which are maximum upto 2 repeat doses (repeat dose given after 6-12 hours of previous dose)
dose of repeat course is 100 mg/kg.
Control Intervention1: NIL: NIL
Sponsors
Dr Meena kadiyala
Eligibility
Inclusion criteria
Inclusion criteria: Infants born at 26 0/7 to 30 0/7 weeks of gestation with features suggestive of RDS on nasal CPAP (with Fio2 requirement more than 30%) within 6 hours after birth, as decided by the treating physician will be included in the study.
Exclusion criteria
Exclusion criteria: Infants who have life-threatening congenital anomalies or were considered non-viable Infants with severe hemodynamic instability, poor respiratory efforts Infants with Fio2 requirement less than 30% Infants who require early intubation and ventilation at birth Infants who were born after prolonged premature rupture of membranes (14 days prior to delivery). Infants who have birth asphyxia (Apgar score of less than 7 at minute 5, umbilical cord pH less than 7, base excess (BE) more than -16) Infants who have anomalies of the upper or lower airway or mandible precluding use of nasal CPAP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Requirement of intubation and mechanical ventilation within 72hours after birth post surfactant administration due to persistent respiratory distress with high FIO2 requirement (more than 40% ) on nasal CPAP (CPAP failure)Timepoint: Birth to 72 hours of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe adverse events during the LISA procedure defined as prolonged apnea more than 20 seconds with desaturation (SpO2 less than or equal to 80%) and/or bradycardia (HR less than 80 beats/min) requiring up to bag & mask ventilation or escalation to NIPPV support. Transient adverse events during the LISA procedure like desaturation and/or bradycardia not compromising the baby and picking up to normal within few seconds Surfactant reflux during and post procedure as noticed from OGT aspiration Timepoint: During and post procedure;Intubation within 7 days of life Neonatal mortality within 28 days of life Mortality till discharge Requirement of redosing of surfactant Duration of mechanical ventilation Duration of CPAP/NIPPV Pulmonary hemorrhage Air leak syndromes (pneumothorax , pulmonary interstitial emphysema , pneumomediastinum) Total duration of respiratory support Moderate to severe bronchopulmonary dysplasia Composite outcome of death and bronchopulmonary dysplasiaTimepoint: Birth to discharge;Patent ductus arteriosus requiring treatment (hs-PDA) Culture confirmed bacterial / fungal sepsis Necrotising enterocolitis (bell stage II or greater) Intraventricular hemorrhage (IVH any grade) Retinopathy of prematurity (ROP) requiring treatment Total duration of hospital stayTimepoint: Birth to discharge | — |
Countries
India
Contacts
Public ContactDr Giridhar Sethuraman
Chettinad Hospital and Research Institute
Outcome results
None listed