Implementing LISA Surfactant in Nigeria

NCT05714865 | Completed Phase 4

• 1 other identifier: NHREC/01/01/2007-12/10/2022
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• 72-hour mortality

  All cause mortality with 72-hours of life

  72 hours of life

Secondary Outcomes (2)

• In-hospital mortality

  Through hospitalization, an average of 1 day to 10 weeks.

• Difference in RDS score before and after the procedure.

  6 hours post procedure

Study Arms (1)

LISA Arm

EXPERIMENTAL

Eligible subjects who have respiratory distress syndrome (Anderson Silverman Score \>4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP.

Drug: Surfactant

Interventions

Surfactant DRUG

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

Also known as: BLES® Surfactant, BLEScath™, Less Invasive Surfactant Administration

LISA Arm

Eligibility Criteria

• Age: 1 Hour - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• BLES Biochemicals Inc.: collaborator

Study Sites (6)

Federal Medical Center Asaba

Asaba, Delta, 11111, Nigeria

Location

University of Benin Teaching Hospital

Benin City, Edo, 11111, Nigeria

Location

National Hospital Abuja

Garki, FCT Abuja, 11111, Nigeria

Location

Aminu Kano Teaching Hospital

Zaria, Kano State, 11111, Nigeria

Location

Lagos University Teaching Hospital.

Idi Araba, Lagos, 11111, Nigeria

Location

University of Nigeria Teaching Hospital

Enugu, 11111, Nigeria

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Perinatal Death

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Osayame A Ekhaguere, MBBS, MPH

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Prospective cohort

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: February 6, 2023
• Study Start: June 25, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NG (6)