Implementing LISA Surfactant in Nigeria

Phase 4

Recruiting

• Conditions: Respiratory Distress Syndrome; Neonatal Death
• Interventions: Drug: Surfactant

• Registration Number: NCT05714865
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-06
• Study Start: 2023-06-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LISA Arm	Surfactant	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.

Primary Outcome Measures

Name	Time	Method
72-hour mortality	72 hours of life	All cause mortality with 72-hours of life

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Federal Medical Center Asaba; 🇳🇬 Asaba, Delta State, Nigeria

University of Benin Teaching Hospital; 🇳🇬 Benin City, Edo State, Nigeria

Aminu Kano Teaching Hospital; 🇳🇬 Zaria, Kano, Nigeria

Lagos University Teaching Hospital.; 🇳🇬 Idi-Araba, Lagos, Nigeria

National Hospital Abuja; 🇳🇬 Garki, FCT Abuja, Nigeria

University of Nigeria Teaching Hospital; 🇳🇬 Enugu, Nigeria