Feasibility of Uninterrupted Infant Respiratory Support Treatment

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Karolinska Institutet
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Updated on 16 February 2024
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cesarean section
continuous positive airway pressure

Summary

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.

Details
Condition respiratory distress syndrome of newborn, Neonate, Respiratory Insufficiency Syndrome of Newborn
Age 100years or below
Treatment Uninterrupted CPAP for the first hours of life
Clinical Study IdentifierNCT04244890
SponsorKarolinska Institutet
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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