RecruitingPhase 4NCT06554522

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa


Sponsor

Indiana University

Enrollment

1,512 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 HourMax Age: 24 Hours

Inclusion Criteria3

  • 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 Criteria3

  • Major congenital or genetic anomalies.
  • Active pulmonary hemorrhage.
  • Major craniofacial anomalies that preclude the successful use of CPAP

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Interventions

DRUGSurfactant

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


Locations(8)

Centre Hospitalier Universitaire Communautaire

Bangui, Central African Republic

Korle-Bu Teaching Hospital

Accra, Ghana

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Tamale Teaching Hospital

Tamale, Ghana

Coast General Teaching & Referral Hospital

Mombasa, Kenya

Mama Lucy Kibaki Hospital

Nairobi, Kenya

Federal Teaching Hospital Ido-Ekiti

Ido-Ekiti, Ekiti State, Nigeria

University of Ilorin Teaching Hospital

Ilorin, Kwara State, Nigeria

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NCT06554522


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