Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Less Invasive Surfactant Administration, LISA, Lung Ultrasound, Neonatology, Surfactant Distribution Homogeneity Index
Brief 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). 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
PROCEDUREsurfactant 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.
PROCEDUREsurfactant 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).
Sponsors
Hamad General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 42 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surfactant Distribution Homogeneity Index (SDHI) Derived from Lung Ultrasound Imaging scores pre and at 60 Minutes Post-Surfactant Administration. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Lung Ultrasound Score (LUS) from Baseline to 60 Minutes Post-Surfactant Administration | 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) |
| Number of Participants Requiring Invasive Mechanical Ventilation Following Initial Surfactant Administration | 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) |
| Number of Participants Requiring a Second Dose of Surfactant Due to Persistent Respiratory Distress Syndrome | 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) |
Countries
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Contacts
CONTACTLoay A Alkamel, MD, Mac
Outcome results
None listed