Implementing LISA Surfactant in Nigeria

NCT ID: NCT05714865

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-25
• Study Completion Date: 2025-03-30

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.

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.

Conditions

Respiratory Distress Syndrome; Neonatal Death

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Surfactant

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

BLES® Surfactant; BLEScath™; Less Invasive Surfactant Administration

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 abnormality
• Any preterm infant considered nonviable by the managing clinician.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BLES Biochemicals Inc.

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Osayame Ekhaguere

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osayame A Ekhaguere, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Federal Medical Center Asaba

Asaba, Delta, Nigeria

University of Benin Teaching Hospital

Benin City, Edo, Nigeria

National Hospital Abuja

Garki, FCT Abuja, Nigeria

Aminu Kano Teaching Hospital

Zaria, Kano State, Nigeria

Lagos University Teaching Hospital.

Idi-Araba, Lagos, Nigeria

University of Nigeria Teaching Hospital

Enugu, , Nigeria

Countries

Nigeria

Other Identifiers

NHREC/01/01/2007-12/10/2022

Identifier Type: -

Identifier Source: org_study_id