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Implementing LISA Surfactant in Nigeria

NCT05714865 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome
  • Neonatal Death

Interventions

DRUG

Surfactant

Laryngoscopy is performed, and BLES® surfactant is administered through BLEScath™ (a thin catheter) into the trachea to a spontaneously breathing preterm infant with respiratory distress syndrome who is being managed on CPAP

Sponsors & Collaborators

  • BLES Biochemicals Inc.

    collaborator UNKNOWN

  • Indiana University

    lead OTHER

Principal Investigators

  • Osayame A Ekhaguere, MBBS, MPH · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-25
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714865 on ClinicalTrials.gov