NCT06554522 Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
| NCT ID | NCT06554522 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Respiratory Distress Syndrome in Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,512 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,512 participants in total. It began in 2025-01-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Osayame A Ekhaguere, MBBS, MPH
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06554522 clinical trial?
This trial is open to participants of all sexes, aged 1 Hour or older, up to 24 Hours, studying Respiratory Distress Syndrome in Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06554522 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06554522 currently recruiting?
Yes, NCT06554522 is actively recruiting participants. Contact the research team at osaekhag@iu.edu for enrollment information.
Where is the NCT06554522 trial being conducted?
This trial is being conducted at Bangui, Central African Republic, Accra, Ghana, Kumasi, Ghana, Tamale, Ghana and 4 additional locations.
Who is sponsoring the NCT06554522 clinical trial?
NCT06554522 is sponsored by Indiana University. The principal investigator is Osayame A Ekhaguere, MBBS, MPH at Indiana University. The trial plans to enroll 1,512 participants.