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Feasibility of Uninterrupted Infant Respiratory Support Treatment — FUIRST  

Infant, Newborn Clinical Trial

Official title:
Feasibility of Respiratory Management of Infants Needing Positive Pressure Ventilation or CPAP, Using a Single System to Deliver Uninterrupted Support Directly at Birth and the First Hours of Life

Clinical Trial Summary

Feasibility study of a simplified respiratory support system for newborn infants

Clinical Trial Description

The study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. The study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system. The system is a modified version of the commercially available rPAP system. The revised design has a simplified gas supply and allows elimination of a complicated driver. The new system has low resistance to breathing equal to the rPAP system. The study will recruit 40-60 infants in a single centre without a comparison arm. The trial is conducted as a first step towards a large randomised trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04244890
Study type Observational
Source Karolinska Institutet
Contact
Status Completed
Phase
Start date February 21, 2020
Completion date February 1, 2023
View Details
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