Feasibility of Uninterrupted Infant Respiratory Support Treatment (FUIRST)

Karolinska Institute

Status: Completed

Conditions: Infant, Newborn; Respiratory Insufficiency Syndrome of Newborn; Respiratory Distress Syndrome, Newborn

Treatments: Device: Uninterrupted CPAP for the first hours of life

Study type: Observational

Funder types: Other

Identifiers

NCT04244890

2019-05581

Details and patient eligibility

About

Feasibility study of a simplified respiratory support system for newborn infants

Full 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.

Enrollment: 32 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vaginal delivery at gestational age between 28+0 and 34+6
• Caesarean section at gestational age between 28+0 and 37+6
• Infants in need of respiratory support in delivery-room

Exclusion criteria

• Carciac malformations
• Airway malformations
• Known syndromes or neuromuscular disorders
• Transfer to other hospital within 4 hours likely

Trial design

32 participants in 1 patient group

Uninterrupted CPAP

Description:

Newborn infants in need of respiratory support directly after birth

Treatment:

Device: Uninterrupted CPAP for the first hours of life