LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study (LISA-Ven-LUS)

April 1, 2026 updated by: Loay Alkamel, Hamad General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Qatar
      • Doha, Qatar
        • Recruiting
        • Women's Wellness and Research Center (WWRC), Hamad Medical Corporation
        • Contact:
        • Sub-Investigator:
          • Husam Salameh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm 1: LISA Group
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).
Procedure: surfactant administration by thin catheter
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).
Other Names:
  • LISA
Experimental: ETT Group
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.
Procedure: surfactant administration by ETT
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surfactant Distribution Homogeneity Index (SDHI) Derived from Lung Ultrasound Imaging scores pre and at 60 Minutes Post-Surfactant Administration.
Time Frame: Baseline (immediately before administration) and 60 minutes (+/- 15 min) post-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
Baseline (immediately before administration) and 60 minutes (+/- 15 min) post-administration.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Total Lung Ultrasound Score (LUS) from Baseline to 60 Minutes Post-Surfactant Administration
Time Frame: Baseline and 60 minutes post-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)
Baseline and 60 minutes post-administration.
Number of Participants Requiring Invasive Mechanical Ventilation Following Initial Surfactant Administration
Time Frame: Within 72 hours post-intervention.

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)
Within 72 hours post-intervention.
Number of Participants Requiring a Second Dose of Surfactant Due to Persistent Respiratory Distress Syndrome
Time Frame: Up to 72 hours of life.

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)
Up to 72 hours of life.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamad General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRC-01-25-899 Abhath-HMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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