Status:
RECRUITING
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Open Philanthropy
Conditions:
Respiratory Distress Syndrome in Premature Infant
RDS of Prematurity
Eligibility:
All Genders
1-24 years
Phase:
PHASE4
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...
Detailed Description
The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. S...
Eligibility Criteria
Inclusion
- 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
- Major congenital or genetic anomalies.
- Active pulmonary hemorrhage.
- Major craniofacial anomalies that preclude the successful use of CPAP
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
1512 Patients enrolled
Trial Details
Trial ID
NCT06554522
Start Date
January 1 2025
End Date
December 30 2027
Last Update
April 7 2025
Active Locations (8)
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1
Centre Hospitalier Universitaire Communautaire
Bangui, Central African Republic
2
Korle-Bu Teaching Hospital
Accra, Ghana
3
Komfo Anokye Teaching Hospital
Kumasi, Ghana
4
Tamale Teaching Hospital
Tamale, Ghana