NCT07514481 LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
| NCT ID | NCT07514481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hamad General Hospital |
| Condition | Respiratory Distress Syndrome, Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-07-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This prospective, non-randomized, unblinded pilot study evaluates and compares the intrapulmonary distribution of exogenous surfactant in preterm neonates when administered via Less Invasive Surfactant Administration (LISA) versus conventional endotracheal intubation (ETT). Lung ultrasound (LUS) will be utilized to assess the pioneer Surfactant Distribution Homogeneity Index (SDHI) to quantify the evenness and extent of surfactant-induced lung aeration. Secondary objectives include evaluating changes in LUS scores, short-term clinical respiratory outcomes, and feasibility parameters for guiding future larger-scale trials.
Eligibility Criteria
Inclusion Criteria: Gestational age 24+0 to 42+6 weeks. Clinical and radiographic diagnosis of Respiratory Distress Syndrome (RDS). Requirement for surfactant within the first 3 days of life. Written informed parental consent. Exclusion Criteria: Infants intubated at birth or who received surfactant prophylactically in the delivery room. Major congenital anomalies or lung malformations (e.g., congenital diaphragmatic hernia, pulmonary hypoplasia). Syndromic or genetic conditions affecting lung or chest wall development. Severe hemodynamic instability or congenital heart disease requiring intensive support. Lack of parental consent for trial participation.