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Not Yet Recruiting NCT05714865

Implementing LISA Surfactant in Nigeria

Conditions: Respiratory Distress Syndrome, Neonatal Death

Sex: All
Ages: 1 Hour – 2 Days
Phase: PHASE4
Enrollment: 480
Sponsor: Indiana University

Location: Nigeria

Summary

Implement Less Invasive Surfactant Administration 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.

Eligibility Criteria

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 abnormalityAny preterm infant considered nonviable by the managing clinician.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05714865). StuddyBuddy aggregates publicly available trial information.