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Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Sponsor: Indiana University
Summary
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.
Official title: Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
Key Details
Gender
All
Age Range
1 Hour - 24 Hours
Study Type
INTERVENTIONAL
Enrollment
1512
Start Date
2025-01-01
Completion Date
2027-12-30
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Surfactant
Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)
Locations (8)
Centre Hospitalier Universitaire Communautaire
Bangui, Central African Republic
Korle-Bu Teaching Hospital
Accra, Ghana
Komfo Anokye Teaching Hospital
Kumasi, Ghana
Tamale Teaching Hospital
Tamale, Ghana
Coast General Teaching & Referral Hospital
Mombasa, Kenya
Mama Lucy Kibaki Hospital
Nairobi, Kenya
Federal Teaching Hospital Ido-Ekiti
Ido-Ekiti, Ekiti State, Nigeria
University of Ilorin Teaching Hospital
Ilorin, Kwara State, Nigeria