LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surfactant administration by ETT, surfactant administration by thin catheter.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome, Newborn. Basic parameters: 24 Weeks — 42 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Qatar
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
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.
Interventions
- 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. - 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).
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- Change in Total Lung Ultrasound Score (LUS) from Baseline to 60 Minutes Post-Surfactant Administration [Time frame: Baseline and 60 minutes post-administration.]
- Number of Participants Requiring Invasive Mechanical Ventilation Following Initial Surfactant Administration [Time frame: 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.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Qatar · 1 center
- Women's Wellness and Research Center (WWRC), Hamad Medical Corporation — Doha
Identifiers
NCT: NCT07514481 · MRC-01-25-899 Abhath-HMC