Implementing LISA Surfactant in Nigeria

Less Invasive Surfactant Administration in Nigeria

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Neonatal Death
• Intervention / Treatment: Drug: Surfactant

Detailed Description

Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for ~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA.

Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%.

PICO Outline:

Population: Preterm infants </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.

Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.

Comparator: A historical control of preterm babies </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.

Outcome measures:

Primary Outcome: 72-hour all-cause in-hospital mortality.

Secondary outcomes

• All-cause in-hospital mortality
• Change in respiratory distress score, pre- to -post interventions.

• Study Type: Interventional
• Enrollment (Actual): 349
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nigeria
  • Enugu, Nigeria, 11111
    • University of Nigeria Teaching Hospital
  • Delta State
    • Asaba, Delta State, Nigeria, 11111
      • Federal Medical Center Asaba
  • Edo State
    • Benin City, Edo State, Nigeria, 11111
      • University of Benin Teaching Hospital
  • FCT Abuja
    • Garki, FCT Abuja, Nigeria, 11111
      • National Hospital Abuja
  • Kano
    • Zaria, Kano, Nigeria, 11111
      • Aminu Kano Teaching Hospital
  • Lagos
    • Idi-Araba, Lagos, Nigeria, 11111
      • Lagos University Teaching Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LISA Arm; 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; 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; Other Names: BLES® Surfactant; BLEScath™; Less Invasive Surfactant Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
72-hour mortality	All cause mortality with 72-hours of life	72 hours of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	All cause mortality during hospitalization	Through hospitalization, an average of 1 day to 10 weeks.
Difference in RDS score before and after the procedure.	Change in Anderson Silverman RDS Score before and after intervention (range: 0 to 10)	6 hours post procedure

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: BLES Biochemicals Inc.
• Investigators: Principal Investigator: Osayame A Ekhaguere, MBBS, MPH, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2023
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Death; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Perinatal Death; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: NHREC/01/01/2007-12/10/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On request and approval from local principal investigators and ethical approval committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No