Implementing LISA Surfactant in Nigeria

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: BLES Pharmaceuticals
• Treatments: Pulmonary Surfactants

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 abnormality

• Any preterm infant considered nonviable by the managing clinician.