Health Condition 1: null- Preterm neonates with Respiratory Distress Syndrome
Conditions
Interventions
Intervention1: Goat lung surfactant extract: Intratracheal administration in dose of 100 mg/kg to be administered as a single dose over 5 to 10 minutes once the baby meets the criteria of respiratory
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Neonates born at the study sites and fulfilling all of the following criteria will be eligible for enrolment in the study 1. Gestational age less than or equal to 32 completed weeks 2. Onset of respiratory distress within six hours of age 3. If baby meets criteria for surfactant replacement therapy: a. FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or b. Baby needs intubation because of CPAP failure or severe respiratory distress (Chest X-ray is not mandatory for deciding the need for SRT).
Exclusion criteria
Exclusion criteria: Neonates with any of the following criteria will be excluded: 1.Gestation below 26 wk 2.Babies with severe birth asphyxia as defined by the need for chest compressions and/or initial (umbilical arterial/or within 1 hour of birth) pH 3. Major congenital malformations 4. Prophylactic surfactant administration, i.e. administration of surfactant before the infant develops respiratory distress 5.Air leak or pulmonary hemorrhage prior to enrollment 6.Shock requiring vasopressor support prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BPD free survivalTimepoint: 36 weeks of post-menstrual age which means an postnatal age of 4 to 10 weeks after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any air leak within 72 hours of administration of surfactantTimepoint: Occurrence of any airleak -pneumothorax, PIE or pneumomediastinum in chest X-ray (done when clinically suspected);Area under the curve for (AUC) for oxygen requirement (FiO2) requirement in first 48 hTimepoint: The oxygen requirement will be recorded every hour using a standardized protocol and AUC for first 48 hrs will be calculated;Duration of hospital stayTimepoint: until discharge;Duration of mechanical ventilation and CPAPTimepoint: Cumulative duration of mechanical ventilation and CPAP until discharge/death;IVH grade 3 or 4Timepoint: At 72±24 hrs after birth;Neonatal mortalityTimepoint: Death of a neonate in first 28 days of life;Pulmonary hemorrhageTimepoint: Occurrence of bleeding/blood stained secretions from the trachea within 48 hr of surfactant administration;PVL-cystic and non-cysticTimepoint: Ultrasonography would be carried out by a radiologist/neonatologist at 72±24 hrs, 28±7days;Respiratory support at 72 h and 7 days of ageTimepoint: 72 hours and 7 days of age;Retinopathy of prematurity (ROP)Timepoint: Eyes of the babies would be examined by the ophthalmologists starting from 4 wk of life;SepsisTimepoint: Occurrence of any episode of sepsis (culture positive or culture negative) from the time of enrolment until 7 days of age | — |
Countries
India
Contacts
Public ContactRamesh Agarwal
All India Institute of Medical Sciences
Outcome results
None listed