Evaluating a new surfactant treatment for respiratory distress in preterm infants in Africa
Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
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 |
| Enrollment | 1512 (estimated) |
| Ages | 1 Hour to 24 Hours |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 8 sites (Bangui and 7 other locations) |
| Trial ID | NCT06554522 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bangui and 7 other locations
- 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)
- Coast General Teaching & Referral Hospital — Mombasa, Kenya (Not_yet_recruiting)
- Mama Lucy Kibaki Hospital — Nairobi, Kenya (Not_yet_recruiting)
- Federal Teaching Hospital Ido-Ekiti — Ido-Ekiti, Ekiti State, Nigeria (Recruiting)
- University of Ilorin Teaching Hospital — Ilorin, Kwara State, Nigeria (Recruiting)
Study contacts
- Principal investigator: Osayame A Ekhaguere, MBBS, MPH — Indiana University
- Study coordinator: Osayame A Ekhaguere
- Email: osaekhag@iu.edu
- Phone: +13179443691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.