Neonatal Diseases
Conditions
Interventions
Intubate Surfactant administer Extubate InSurE
Surfactant Administration via Supraglottic airway device
Sponsors
Bill and Melinda Gates Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gestational age 28 0/7 -36 6/7 weeks Birthweight 1000 grams or greater Inborn Spontaneously breathing Clinical diagnosis of RDS and meeting surfactant criteria within 24 hours from birth Downes’ score of 4 or greater CPAP = 6 cmH20 and FiO2 = 0.4 to maintain saturations 90-95% CPAP optimized and safety check complete
Exclusion criteria
Exclusion criteria: Surfactant criteria first met when infant is > 24 hours from birth Lack of CPAP optimization: CPAP < 6 cmH20 or safety check incomplete Previous treatment with surfactant or mechanical ventilation via an endotracheal tube Urgent need for intubation and mechanical ventilation as determined by the treating clinician Known pneumothorax Major congenital anomaly of lungs, heart or airway Apgar < 3 at 5 minutes Not receiving full active intensive care (i.e. palliative or comfort care)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without receiving or reaching criteria for mechanical ventilation at 72 hours post randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival to 72 hours post randomization ;Survival to hospital discharge ;Receiving mechanical ventilation prior to hospital discharge ;Among survivors discharged home in room air, length of treatment with respiratory support (mechanical ventilator, CPAP, high flow nasal cannula and intranasal oxygen) ;Postmenstrual age at hospital discharge amongst survivors ;Any chronic lung disease (grade 1-3 at 36 weeks’ PMA) Any retinopathy of prematurity (stage 1-5) Any intraventricular hemorrhage (grade 1-4) Late-onset sepsis Pharmacologic treatment of Patent Ductus Arteriosus (PDA) ;Successful device placement on first attempt (%) Number of attempts for successful device placement (n) Total procedural time (minutes) Received non-pharmacologic procedural pre-medications (%) Received pharmacologic procedural pre-medications (%) Received assigned treatment (%) Number of airway clinicians that attempted procedure Professional experience of person administering surfactant ;Inpatient hospital costs per patient Out-of-pocket expenses per patient | — |
Countries
Ethiopia, Kenya, Nigeria
Contacts
Public ContactMalet;Danielle Gizaw ;Ehret
Neonatologist;Director of Global Health at VON Neonatologist
Outcome results
None listed