NCT04244890

Feasibility of Uninterrupted Infant Respiratory Support Treatment

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Feasibility study of a simplified respiratory support system for newborn infants

Detailed 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.

Conditions

• Respiratory Distress Syndrome, Newborn
• Infant, Newborn
• Respiratory Insufficiency Syndrome of Newborn

Interventions

Type	Name	Description
DEVICE	Uninterrupted CPAP for the first hours of life	Directly at birth the infant will be supported with PPV with PEEP as needed, followed by nasal CPAP. Support will be provided with a single device for up to four hours.

Timeline

• Start date: 2020-02-21
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2020-01-28
• Last updated: 2023-02-03

Locations

1 site across 1 country: Sweden