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Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

NCT06554522 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1512

Last updated 2026-03-27

No results posted yet for this study

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 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

  • Respiratory Distress Syndrome in Premature Infant
  • RDS of Prematurity
  • Surfactant Deficiency Syndrome Neonatal
  • Premature Birth

Interventions

DRUG

Surfactant

Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)

Sponsors & Collaborators

  • Coefficient Giving (Formerly Open Philanthropy)

    collaborator UNKNOWN

  • Indiana University

    lead OTHER

Principal Investigators

  • Osayame A Ekhaguere, MBBS, MPH · Indiana University

  • Helen Nabwera, BMedSci · Aga Khan University

  • Olufunke Bolaji, MBBS · Afe Babalola University

  • Edgardo Szyld, MD, MS · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-09-30
Completion
2027-12-30

Countries

  • Central African Republic
  • Ghana
  • Kenya
  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554522 on ClinicalTrials.gov