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LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study

RecruitingNAAges 24 Weeks - 42 WeeksAllHamad General Hospital
NCT07514481 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • surfactant administration by ETT
  • surfactant administration by thin catheter
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Where

1 site
Women's Wellness and Research Center (WWRC), Hamad Medical Corporation
Doha, Qatar
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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