A Randomized, Multicenter Study of the Safety and Performance of Fabian PRICO for Saturation Targeting With Non-invasive Respiratory Support

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

UNKNOWN

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-08-31

Brief Summary

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This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-PRICO with noninvasive ventilation and its safety and performance at targeting and maintaining accurate SpO2 levels.

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Detailed Description

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This is a randomized cross-over study. Subjects will be assigned to two, nominally 12-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random.

In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF.

This study has no additional follow-up visits.

Conditions

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Respiratory Insufficiency Syndrome of Newborn

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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fabian Therapy evolution ventilators with PRICO (Predictive Intelligent Control of Oxygenation)

12 hours Automated PRICO FiO2 control

Intervention Type DEVICE

fabian Therapy evolution ventilators with manual FiO2 control

12 hours Manual PRICO FiO2 control

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian Therapy evolution ventilator
* \<37 + 0 weeks gestation
* \<10 kg at study entry
* FiO2 \> 0.25
* Informed consent form obtained as per EC requirements

Exclusion Criteria

* Not expected to complete 24 hours of non-invasive respiratory support
* Congenital anomalies
* Uncontrolled hemodynamics
* Severe airflow obstruction
* Intracranial hypertension
* Start of caffeine therapy within 12 hours
* Attending physician does not believe participation in the study is in the patient's best interest

Minimum Eligible Age

0 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No