CompletedPhase 4

Implementing LISA Surfactant in Nigeria

Nigeria349 participantsStarted 2023-06-25

Plain-language summary

Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.

Who can participate

Age range1 Hour – 2 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable). * ≤48 Hours old at recruitment. * Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP. * Admitted to the neonatal/newborn units (or special care nurseries). Exclusion Criteria: * Any newborn intubated before admission to the neonatal/newborn units. * Any newborn infants with a significant congenital abnormality * Any preterm infant considered nonviable by the managing clinician.

What they're measuring

72-hour mortality

Timeframe: 72 hours of life

Trial details

NCT IDNCT05714865

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

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