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โ† Trials
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Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

RecruitingPhase 4Ages 1 Hour - 24 HoursAllIndiana University
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In plain words

What the trial is, and whether it could suit you

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 w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks. * Silverman Anderson Score โ‰ฅ5 before or after CPAP treatment. * Admitted to a study site within 24 hours of life. Exclusion Criteria: * Major congenital or genetic anomalies. * Active pulmonary hemorrhage. * Major craniofacial anomalies that preclude the successful use of CPAP
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What it tests

  • Surfactant
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Where

8 sites
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, Nigeria
University of Ilorin Teaching Hospital
Ilorin, Nigeria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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