NCT04056741

Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: ONY · Industry
• Sex: All
• Age: 24 Weeks
• Healthy volunteers: Not accepted

Summary

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Detailed description

Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

Conditions

• RDS of Prematurity
• Surfactant Protein B Deficiency
• Chronic Lung Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	surfactant airway device	Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.

Timeline

• Start date: 2025-02-07
• Primary completion: 2025-12-12
• Completion: 2026-03-12
• First posted: 2019-08-14
• Last updated: 2023-11-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study