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.
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