Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Less invasive surfactant administration: Neonates randomized to the intervention group would receive Curosurf (Poractant alpha) in a dose of 200 mg/kg via a 5 Fr infant feeding tube.
A
Sponsors
All India Instiute of Medical Sciences AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: All spontaneously breathing neonates with gestation age between 27 0/7 weeks to 34 6/7 with 1.Onset of respiratory distress within 6 hours of birth requiring CPAP and meeting the criteria for surfactant replacement with FiO2 of 40% or higher to maintain oxygen saturation between 90%-95% OR 2.Fulfils the criteria for Prophylactic Surfactant replacement therapy
Exclusion criteria
Exclusion criteria: 1.Any positive pressure ventilation by endotracheal tube prior to giving surfactant 2.Major congenital malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Fio2 requirement of spontaneously breathing neonates (gestation age between 27 0/7 weeks and 34 6/7 weeks) requiring surfactant replacement therapyTimepoint: Within 6 hours of surfactant replacement therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Air leak within 72 hours/anytime (%)Timepoint: during hospital stay;AUC for FiO2 within 6 hours post surfactant administrationTimepoint: After 6 hours of SRT;Bronchopulmonary dysplasia (BPD) (%) Timepoint: at 36 weeks PMA;Duration of oxygen therapy (days)Timepoint: during hospital stay;Duration of respiratory support (CPAP/H3FNC/ventilation â?? days)Timepoint: during hospital stay;Hemodynamically significant patent ductus srteriosus (HS PDA) (%) Timepoint: at 3 days and as and when clinical team has a suspicion of PDA;Increment in CPAP or PIP/PEEP in during and till 15 minutes post procedureTimepoint: Within 15 mins of completion of procedure;Intraventricular haemorrhage (IVH) grade 3 and 4 (%) Timepoint: at 3 days, 28 days postnatal age and 40 weeks PMA;Mortality (%)Timepoint: Till the time of death or discharge;Necrotising enterocolitis (NEC) stage 2 or more (%) Timepoint: During hospital stay;Need for intubation within 1 and 3 hours Timepoint: 1 st hour after SRT and 3 hours after SRT;Need for mechanical ventilation at 72 hours of life (%)Timepoint: 72 hours of life;Need for MV anytime during hospital stay (%) Timepoint: During hospital stay;Periventricular leukomalacia (PVL) (%) Timepoint: at 28 days post natal age and 40 weeks PMA;Proportion of neonates having apnea during the procedureTimepoint: During the procedure;Proportion of neonates having bradycardiaTimepoint: During the procedure;Proportion of neonates having episodes of desaturation Timepoint: During the procedure;Proportion of neonates having episodes of reflux, choking and gagging Timepoint: During the procedure;Proportion of neonates requiring INSURE for giving surfactantTimepoint: During the procedure;Proportion of neonates requiring PPV during the procedure Timepoint: During the procedure;Proportion of neonates with failed attempts of tracheal catheterization or intubationTimepoint: During the procedure;Pulmonary hemorrhage Timepoint: During hospital stay;Sepsis (pre and post SRT) (% | — |
Countries
India
Contacts
Public ContactDr Anu Sachdeva
Division of Neonatology, Department of Pediatrics,AIIMS, New Delhi
Outcome results
None listed