Actively Recruiting
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Led by Indiana University · Updated on 2026-03-27
1512
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
C
Coefficient Giving (Formerly Open Philanthropy)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks
- Silverman Anderson Score 5 or higher before or after CPAP treatment
- Admitted to a study site within 24 hours of life
You will not qualify if you...
- Major congenital or genetic anomalies
- Active pulmonary hemorrhage
- Major craniofacial anomalies that preclude the successful use of CPAP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Centre Hospitalier Universitaire Communautaire
Bangui, Central African Republic
Not Yet Recruiting
2
Korle-Bu Teaching Hospital
Accra, Ghana
Not Yet Recruiting
3
Komfo Anokye Teaching Hospital
Kumasi, Ghana
Not Yet Recruiting
4
Tamale Teaching Hospital
Tamale, Ghana
Not Yet Recruiting
5
Coast General Teaching & Referral Hospital
Mombasa, Kenya
Not Yet Recruiting
6
Mama Lucy Kibaki Hospital
Nairobi, Kenya
Not Yet Recruiting
7
Federal Teaching Hospital Ido-Ekiti
Ido-Ekiti, Ekiti State, Nigeria
Actively Recruiting
8
University of Ilorin Teaching Hospital
Ilorin, Kwara State, Nigeria
Actively Recruiting
Research Team
O
Osayame A Ekhaguere
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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