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Feasibility of Uninterrupted Infant Respiratory Support Treatment

Feasibility of Uninterrupted Infant Respiratory Support Treatment

Recruiting
100 years and younger
All
Phase N/A

Overview

Feasibility study of a simplified respiratory support system for newborn infants

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.

Eligibility

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

Study details
    respiratory distress syndrome of newborn
    Neonate
    Respiratory Insufficiency Syndrome of Newborn

NCT04244890

Karolinska Institutet

16 February 2024

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