Feasibility of Uninterrupted Infant Respiratory Support Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2023-02-01

Brief Summary

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Feasibility study of a simplified respiratory support system for newborn infants

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Detailed Description

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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

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Uninterrupted CPAP

Newborn infants in need of respiratory support directly after birth

Uninterrupted CPAP for the first hours of life

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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