Implementing LISA Surfactant in Nigeria

Respiratory Distress Syndrome Clinical Trial

Official title: Less Invasive Surfactant Administration in Nigeria

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neonatal Death
• Perinatal Death
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

• NCT number: NCT05714865
• Study type: Interventional
• Source: Indiana University
• Contact: Osayame A Ekhaguere, MBBS
• Phone: +1 (317) 944 3691
• Email: osaekhag@iu.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2023
• Completion date: September 30, 2024