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Study identifier: NCT06554522 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Condition: Respiratory Distress Syndrome in Premature Infant · RDS of Prematurity · Surfactant Deficiency Syndrome Neonatal  ·  Sponsor: Indiana University

PhasePhase 4
Planned participants1512
Who can joinAll sexes, 1 Hour to 24 Hours
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Osayame A Ekhaguere  ·  +13179443691  ·  osaekhag@iu.edu

Always discuss trial participation with your own doctor first.

Locations (8)

Centre Hospitalier Universitaire CommunautaireBangui, Central African RepublicNot Yet Recruiting
Korle-Bu Teaching HospitalAccra, GhanaNot Yet Recruiting
Komfo Anokye Teaching HospitalKumasi, GhanaNot Yet Recruiting
Tamale Teaching HospitalTamale, GhanaNot Yet Recruiting
Coast General Teaching & Referral HospitalMombasa, KenyaNot Yet Recruiting
Mama Lucy Kibaki HospitalNairobi, KenyaNot Yet Recruiting
Federal Teaching Hospital Ido-EkitiIdo-Ekiti, Ekiti State, NigeriaRecruiting
University of Ilorin Teaching HospitalIlorin, Kwara State, NigeriaRecruiting

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Source record: clinicaltrials.gov/study/NCT06554522