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RECRUITING
NCT06554522
PHASE4

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Sponsor: Indiana University

View on ClinicalTrials.gov

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

Interventions

DRUG

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