Implementing LISA Surfactant in Nigeria

Respiratory Distress Syndrome Clinical Trial

Official title:

Less Invasive Surfactant Administration in Nigeria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714865
• Other study ID #: NHREC/01/01/2007-12/10/2022
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: Osayame A Ekhaguere, MBBS
• Phone: +1 (317) 944 3691
• Email: osaekhag[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 2 Days

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	BLES Biochemicals Inc.

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	72-hour mortality	All cause mortality with 72-hours of life	72 hours of life
Secondary	In-hospital mortality	All cause mortality during hospitalization	Through hospitalization, an average of 1 day to 10 weeks.
Secondary	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