LISA versus endotracheal surfactant distribution in preterm babies
Official title: 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)
Run by Hamad General Hospital · NCT07514481 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 24 Weeks to 42 Weeks |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | Hamad General Hospital Government |
| Locations | 1 site (Doha) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 30, 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07514481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Lung ultrasound score to guide surfactant timing in preterm newborns
This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.
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Predicting which newborns in a lower-level NICU will need extended breathing support
This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.
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Optimising breathing support at extubation for very preterm infants
This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.
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Evaluating lung ultrasound after surfactant treatments in preterm babies
This study tests how different ways of giving surfactant treatment affect lung health in preterm babies with breathing problems.
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Using ultrasound to guide surfactant therapy for preterm infants with breathing difficulties
This study is testing if using ultrasound to help give surfactant treatment can improve breathing for preterm infants with respiratory problems compared to the usual methods.
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Minimally invasive surfactant treatment for preterm infants
This study is testing if giving a special lung treatment right after birth using a gentle method can help very premature babies breathe better compared to waiting until they need extra oxygen.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.