LISA versus endotracheal surfactant distribution in preterm babies
A Prospective Pilot Controlled Trial Comparing the Intrapulmonary Distribution of Exogenous Surfactant Between (LISA) and Conventional Endotracheal Intubation in Preterm Neonates With RDS Using Lung Ultrasound and the NOVEL Surfactant Distribution Homogeneity Index (SDHI)
This pilot trial tests whether giving surfactant through a thin catheter (LISA) or through a breathing tube leads to more even surfactant spread in preterm infants with respiratory distress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 24 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Hamad General Hospital Government |
| Locations | 1 site (Doha) |
| Trial ID | NCT07514481 on ClinicalTrials.gov |
What this trial studies
This prospective, non-randomized, unblinded pilot enrolls 22 preterm infants in a tertiary NICU and compares surfactant given via LISA (thin catheter) versus conventional endotracheal tube. High-frequency lung ultrasound is performed immediately before and 60 minutes after surfactant across 12 lung regions to calculate a Surfactant Distribution Homogeneity Index (SDHI). The primary outcome is the change in regional ultrasound scores used to quantify distribution uniformity; secondary outcomes include overall LUS score changes, short-term respiratory clinical outcomes, and feasibility metrics. Results will inform whether a larger randomized trial is warranted and whether lung ultrasound can be used to guide administration techniques.
Who should consider this trial
Good fit: Preterm newborns (gestational age 24+0 to 42+6 weeks) with clinical and radiographic RDS who require surfactant within the first 3 days of life and whose parents give written consent are eligible.
Not a fit: Infants already intubated at birth, those who received prophylactic surfactant in the delivery room, or those with major congenital lung anomalies or severe hemodynamic instability are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could identify a delivery method that produces more even lung aeration and potentially reduce need for mechanical ventilation in preterm infants.
How similar studies have performed: LISA is supported by other studies showing reduced need for mechanical ventilation, but using lung ultrasound to quantify surfactant distribution with an SDHI is a novel, pilot-level application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Doha
- Women's Wellness and Research Center (WWRC), Hamad Medical Corporation — Doha, Qatar (Recruiting)
Study contacts
- Study coordinator: Loay A Alkamel, MD, Mac
- Email: lalkamel@hamad.qa
- Phone: 0097455190326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.