Respiratory Distress Syndrome, NewbornLISA-Ven-LUSNCT07514481
LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
A study testing surfactant administration by ETT and surfactant administration by thin catheter in people with Respiratory Distress Syndrome, Newborn, run by Hamad General Hospital at 1 site in Qatar.
Trial 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). Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- surfactant administration by ETT and surfactant administration by thin catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteQatar
- Study dates
- 1 Jan 2026to 30 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Women's Wellness and Research Center (WWRC), Hamad Medical Corporation
Doha
Loay A Alkamel, MD, Msc, 0097455190326, loay.alkamel@gmail.com
Husam Salameh, MD
About this study
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)
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.
Read the detailed description
Respiratory Distress Syndrome (RDS) is a primary cause of neonatal morbidity, typically managed with exogenous surfactant. While LISA has emerged as a preferred method to avoid mechanical ventilation, the comparative homogeneity of surfactant distribution remains unclear. This pilot study enrolls 22 infants (1:1 allocation) in a tertiary-level Neonatal Intensive Care Unit (NICU). The experimental group receives surfactant via a thin catheter while on non-invasive support, whereas the active comparator group receives surfactant via an endotracheal tube. High-frequency linear probe lung ultrasounds are performed immediately before and 60 minutes post-administration across 12 lung regions. The primary metric, the genuine Surfactant Distribution Homogeneity Index (SDHI), is calculated from regional LUS score changes to assess aeration uniformity.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- surfactant administration by ETT, surfactant administration by thin catheter
- Keywords
- Less Invasive Surfactant Administration, LISA, Lung Ultrasound, Neonatology, Surfactant Distribution Homogeneity Index
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactant administration by ETTProcedure or surgery
Administration of exogenous surfactant (Beractant, 100 mg/kg in 4 mL/kg) via an endotracheal tube following intubation, accompanied by brief mechanical ventilation and extubation if feasible.
surfactant administration by thin catheterProcedure or surgery
Also called LISA
Administration of exogenous surfactant (Beractant, 100 mg/kg in 4 mL/kg) via a thin catheter while the infant is maintained on non-invasive respiratory support (CPAP or NIPPV).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: LISA Group | Placebo comparator | Administration of exogenous surfactant (Beractant, 100 mg/kg in 4 mL/kg) via a thin catheter while the infant is maintained on non-invasive respiratory support (CPAP or NIPPV). Receives: Procedure: surfactant administration by thin catheter |
| ETT Group | Experimental | Administration of exogenous surfactant (Beractant, 100 mg/kg in 4 mL/kg) delivered via an endotracheal tube following intubation, accompanied by brief mechanical ventilation and extubation if feasible. Receives: Procedure: surfactant administration by ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant Distribution Homogeneity Index (SDHI) Derived from Lung Ultrasound Imaging scores pre and at 60 Minutes Post-Surfactant Administration.
A novel metric calculated from the change in regional Lung Ultrasound (LUS) scores before and after surfactant administration. The(SDHI) quantifies the uniformity of surfactant distribution across lung regions. The SDHI will be calculated 1 hour after surfactant administration. A higher SDHI is hypothesised to indicate more homogeneous distribution of surfactant across the lungs. Each infant will have a single SDHI value post-intervention, and this will be compared between the LISA and ETT groups to evaluate whether one administration method achieves superior surfactant distribution homogeneity.
The SDHI evaluates the homogeneity of surfactant distribution using multiple formulations applied to regional LUS score changes across 12 predefined lung regions (anterior, lateral, and posterior zones for both left and right hemithoraces). The computation involves comparing regional LUS improvements
SDHI (dimensionless index); higher values indicate more homogeneous surfactant distribution
Measured: Baseline (immediately before administration) and 60 minutes (+/- 15 min) post-administration.
Secondary outcomes (3)
Change in Total Lung Ultrasound Score (LUS) from Baseline to 60 Minutes Post-Surfactant Administration
The Lung Ultrasound Scoring System (LUSS) will be used to quantify lung aeration. Each of 12 predefined lung regions (anterior, lateral, and posterior zones for both left and right hemithoraces) will be scored on a scale from 0 to 3, where: 0 = normal aeration (no B-lines), 1 = moderate aeration (B-lines <50% of region), 2 = poor aeration (B-lines ≥50% of region), and 3 = consolidation. Higher scores indicate worse aeration. Total LUS score ranges from 0 (best) to 36 (worst). Regional changes will be analyzed by anatomical zone (anterior-posterior, left-right) to assess distribution homogeneity. The primary analysis will report the mean change in total LUS score and regional LUS scores for each study arm, with comparison between LISA and ETT groups.
Scale Name (Unabbreviated): Lung Ultrasound Scoring System (LUSS) Minimum Value: 0 Maximum Value: 36 Higher Scores Indicate: Worse aeration (lower is better outcome)
Measured: Baseline and 60 minutes post-administration.
Number of Participants Requiring Invasive Mechanical Ventilation Following Initial Surfactant Administration
The proportion of infants in each arm (LISA vs. ETT) who require intubation and invasive mechanical ventilation after the initial surfactant dose. This is a binary outcome (yes/no) and will be reported as the number and percentage of participants in each arm requiring mechanical ventilation. Mechanical ventilation is defined as the need for endotracheal intubation with positive pressure ventilation support. The analysis will compare the rate of mechanical ventilation requirement between the two study groups to evaluate whether LISA reduces the need for invasive ventilation compared to standard ETT administration.
Measurement Unit
Count and percentage of participants (0-22 participants per arm)
Measured: Within 72 hours post-intervention.
Number of Participants Requiring a Second Dose of Surfactant Due to Persistent Respiratory Distress Syndrome
The proportion of infants in each arm (LISA vs. ETT) who require a second dose of exogenous surfactant due to persistent or worsening radiographic and clinical evidence of Respiratory Distress Syndrome (RDS). This is a binary outcome (yes/no) and will be reported as the number and percentage of participants in each arm requiring repeat surfactant dosing. Repeat dosing is determined by the clinical team based on persistent RDS criteria, including radiographic findings and clinical respiratory severity. The analysis will compare the rate of repeat surfactant requirement between the two study groups to evaluate the efficacy of each administration method in providing adequate initial surfactant distribution.
Measurement Unit
Count and percentage of participants (0-22 participants per arm)
Measured: Up to 72 hours of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Loay Alkamel, Hamad General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514481
- Sponsor's protocol ID
- MRC-01-25-899 Abhath-HMC
- Acronym
- LISA-Ven-LUS
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No