Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Recruiting Phase 4 Interventional Study
Respiratory Distress Syndrome in Premature Infant RDS of Prematurity Surfactant Deficiency Syndrome Neonatal Premature Birth
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Hour – 24 Hours
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,512 (estimated)
Sponsor
Indiana University · Other
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About This Trial
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: D…
Trial Locations
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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 pulmon…
Contacts

Osayame A Ekhaguere

+13179443691

osaekhag@iu.edu

CONTACT