Evaluating a new surfactant treatment for respiratory distress in preterm infants in Africa
Official title: Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
Run by Indiana University · NCT06554522 · Data updated 2026-11-12
This study is testing a new way to give surfactant treatment to preterm infants with breathing problems in Africa to see if it helps them do better than the usual care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Hour to 24 Hours |
| Sex | All |
| Enrollment | 1512 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 8 sites (Bangui and 7 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06554522 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm neonates weighing between 750 and 2000 grams or born between 24 and 35 weeks of gestation who exhibit respiratory distress.
✕Probably not a fit
Patients with major congenital or genetic anomalies, active pulmonary hemorrhage, or craniofacial anomalies that prevent effective CPAP use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness and safety of a less invasive surfactant administration technique for treating respiratory distress syndrome in preterm infants in low- and middle-income African countries. The study will compare outcomes in infants receiving this new treatment against those receiving standard care with continuous positive airway pressure and caffeine. By focusing on a population that often lacks access to invasive ventilators, the trial seeks to improve survival rates among preterm infants suffering from respiratory distress. The research will also monitor any medical complications arising from the treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for preterm infants with respiratory distress in resource-limited settings.
How similar studies have gone: Previous studies in high-income countries have shown that less invasive surfactant administration can reduce the need for invasive mechanical ventilation and improve outcomes, but this approach is novel in low-resource settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Major congenital or genetic anomalies. * Active pulmonary hemorrhage. * Major craniofacial anomalies that preclude the successful use of CPAP
Where it's running
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Federal Teaching Hospital Ido-Ekiti
Ido-Ekiti, Ekiti State, Nigeria Recruiting -
University of Ilorin Teaching Hospital
Ilorin, Kwara State, Nigeria Recruiting -
Centre Hospitalier Universitaire Communautaire
Bangui, Central African Republic Not yet recruiting -
Korle-Bu Teaching Hospital
Accra, Ghana Not yet recruiting -
Komfo Anokye Teaching Hospital
Kumasi, Ghana Not yet recruiting -
Tamale Teaching Hospital
Tamale, Ghana Not yet recruiting
Show 2 more locations
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Coast General Teaching & Referral Hospital
Mombasa, Kenya Not yet recruiting -
Mama Lucy Kibaki Hospital
Nairobi, Kenya Not yet recruiting
Study contacts
- Principal investigator: Osayame A Ekhaguere, MBBS, MPH — Indiana University
- Study coordinator: Osayame A Ekhaguere
- Email: osaekhag@iu.edu
- Phone: +13179443691
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.