LISA versus SALSA: A non-inferiority trial in LMICs

Catheter versus supraglottic airway surfactant replacement therapy in low-resource countries: A non-inferiority trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202503589804554

Enrollment

382

Registered

2025-03-13

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases Respiratory

Interventions

LISA Group

SALSA group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age between 28 to 36 weeks and birth weight between 1000 to 2500 grams A diagnosis of RDS is defined as a Silverman-Anderson score =5 before or after the initiation of CPAP. Admitted to a study site within 24 hours of life. Eligible for or being managed on CPAP. Requiring FiO2 =0.30 to maintain target SpO2, on CPAP.

Exclusion criteria

Exclusion criteria: Previous treatment with surfactant or mechanical ventilation via an endotracheal tube Urgent need for intubation and mechanical ventilation as determined by the treating clinician. Urgent need for surfactant before eligibility and consent criteria being met. Known pneumothorax. Active pulmonary hemorrhage. Major congenital anomaly of lungs, heart, or airway Not receiving full active intensive care (i.e. palliative/comfort care).

Design outcomes

Primary

Measure	Time frame
The composite outcome of the rate of mechanical ventilation and death	—

Secondary

Measure	Time frame
The need for mechanical ventilation at 72-hours and at hospital disposition. The incidence of death during within 72-hours of admission and at hospital disposition. The difference in the Silverman Anderson Score before and after SALSA and LISA. The incidence and highest grade of intraventricular hemorrhage (IVH): Assessed by ultrasound scan between DOL 3 and 7. The incidence of retinopathy of prematurity (ROP): Assessed as the worst stage by an ophthalmologist in patients <1500 grams at birth. The incidence of bronchopulmonary dysplasia (BPD): Defined as continued need of supplemental oxygen at 28 days of life. The incidence of surgical Necrotizing Enterocolitis (NEC stage IV): Defined as the need for any surgical intervention for a patient with clinical signs of necrotizing enterocolitis. The incidence of clinically diagnosed pneumothorax: Diagnosed with a positive transillumination sign on a symptomatic patient. The changes in BRAT score before and after surfactant administration.	—

Measure

Time frame

The need for mechanical ventilation at 72-hours and at hospital disposition. The incidence of death during within 72-hours of admission and at hospital disposition. The difference in the Silverman Anderson Score before and after SALSA and LISA. The incidence and highest grade of intraventricular hemorrhage (IVH): Assessed by ultrasound scan between DOL 3 and 7. The incidence of retinopathy of prematurity (ROP): Assessed as the worst stage by an ophthalmologist in patients <1500 grams at birth. The incidence of bronchopulmonary dysplasia (BPD): Defined as continued need of supplemental oxygen at 28 days of life. The incidence of surgical Necrotizing Enterocolitis (NEC stage IV): Defined as the need for any surgical intervention for a patient with clinical signs of necrotizing enterocolitis. The incidence of clinically diagnosed pneumothorax: Diagnosed with a positive transillumination sign on a symptomatic patient. The changes in BRAT score before and after surfactant administration.

—

Countries

Ghana

Contacts

Public ContactCharlyne Kilba

Consultant

charlyne.kilba@gmail.com+233206301131

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 10, 2026