Infant Respiratory Distress Syndrome Clinical Trials

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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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 9 months
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Qatar
Women's Wellness and Research Center (WWRC), Hamad Medical Corporation
RECRUITING
Doha
Contact Information
Primary
Loay A Alkamel, MD, Mac
lalkamel@hamad.qa
0097455190326
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 22
Treatments
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).
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.
Related Therapeutic Areas
Sponsors
Leads: Hamad General Hospital

This content was sourced from clinicaltrials.gov