Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Beractant: DOSE-100mg/kg
Frequency-STAT DOSE (repeat dosage only if the response is not optimal)
Route of administration-Intratracheal route by LISA technique
Total duration of such
Sponsors
IPGMER AND SSKM HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: Intramural Preterm babies with gestational age between 28 to 34 weeks diagnosed with RDS and eligible for surfactant administration by LISA technique will be enrolled in this study RDS will be diagnosed clinically initially and later confirmed by chest X-ray.
Exclusion criteria
Exclusion criteria: 1. Baby with major congenital anomaly 2. Perinatal asphyxia 3. Intubated at the delivery room 4. An alternative cause of respiratory distress 5. Any baby requiring mechanical ventilation and surfactant administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the requirement for intubation within 72 hours of life. Timepoint: Within 72 hours of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Complications occurring during the procedure (Surfactant reflux during the procedure, SpO2 85%, hypotension with mean below GA, bradycardia 80 bpm, nasal haemorrhage) 2.Need for the second dose of Surfactant 3.Duration of respiratory support (invasive and non-invasive). 4.Pulmonary hemorrhage 5.Pulmonary air leak syndromes 6.Hemodynamically significant PDA requiring treatment 7.Grade 3 and grade 4 IVH 8.Periventricular Leukomalacia(PVL) 9.ROP requiring Laser treatment 10.NEC stage 2 and above 11.Duration of hospital stay 12.Bronchopulmonary dysplasia(BPD) 13.Death before hospital dischargeTimepoint: TILL HOSPITAL DISCHARGE | — |
Countries
India
Contacts
Public ContactASHADUR ZAMAL
IPGMER AND SSKM HOSPITAL
Outcome results
None listed