Clinical trial NCT05714865: Implementing LISA Surfactant in Nigeria
Official title: Less Invasive Surfactant Administration in Nigeria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Neonatal Death
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: BLES Biochemicals Inc.
First posted: 2023-02-06
Enrollment: 349
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 72-hour mortality
timeFrame: 72 hours of life
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Through hospitalization, an average of 1 day to 10 weeks.
measure: Difference in RDS score before and after the procedure.
timeFrame: 6 hours post procedure
Other outcomes:
Locations:
city: Asaba
country: Nigeria
facility: Federal Medical Center Asaba
state: Delta State
city: Benin City
country: Nigeria
facility: University of Benin Teaching Hospital
state: Edo State
city: Garki
country: Nigeria
facility: National Hospital Abuja
state: FCT Abuja
city: Zaria
country: Nigeria
facility: Aminu Kano Teaching Hospital
state: Kano
city: Idi-Araba
country: Nigeria
facility: Lagos University Teaching Hospital.
state: Lagos
city: Enugu
country: Nigeria
facility: University of Nigeria Teaching Hospital
Study officials:
affiliation: Indiana University School of Medicine
name: Osayame A Ekhaguere, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: