The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:
Receive surfactant replacement therapy by the less invasive surfactant administration technique.
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.
Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
Silverman Anderson Score ≥5 before or after CPAP treatment.
Admitted to a study site within 24 hours of life.
Major congenital or genetic anomalies.
Active pulmonary hemorrhage.
Major craniofacial anomalies that preclude the successful use of CPAP
Crossover
Surfactant
DrugSurfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)
Hospital Survival
Survival to hospital discharge
Incidence of major preterm neonatal morbidity
Intraventricular hemorrhage, Retinopathy of Prematurity, Bronchopulmonary Dysplasia, Surgical Necrotizing Enterocolitis and Culture Positive Sepsis
The incidence of pneumothorax
Air leaks into the space between your lung and chest wall
Hospital survival at seven day
Survival rates assessed at day seven of life
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Indiana University
Lead sponsor
Coefficient Giving (Formerly Open Philanthropy)
Collaborator