Actively Recruiting

Phase 4
Age: 1Hour - 24Hours
All Genders
NCT06554522

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

Age: 1Hour - 24Hours
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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