Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

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

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-10-28

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 the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

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Detailed Description

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This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-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 in Children

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function

24 hours of automated control of FiO2

Intervention Type DEVICE

Manual Control

24 hours of manual control of FiO2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Respiratory insufficiency of infants in the neonatal unit who require respiratory support and supplemental oxygen in one of 4 the therapeutic categories (Intubated HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula).
* \<30 kg at study entry
* Informed Consent Form obtained as per EC requirement

Exclusion Criteria

* Not expected to complete 48 hours of the current respiratory support therapeutic category
* Congenital anomalies
* Uncontrolled hemodynamics
* Severe airflow obstruction
* Intracranial hypertension
* Start of caffeine therapy within 12 hours
* Attending physician does not believe participation of the patient is in their best interest.

Eligible Sex

ALL

Accepts Healthy Volunteers

No