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

Chronic Lung Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04056741
Study type Interventional
Source ONY
Contact
Status Suspended
Phase Phase 2
Start date February 7, 2025
Completion date March 12, 2026
View Details
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