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OpenTrials
Completed

NCT Number: NCT04957472

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

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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Key information

Conditions

Respiratory Insufficiency in Children

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

24 hours of automated control of FiO2

Manual control

Other

24 hours of manual control of FiO2

Primary outcomes

  1. Target Range Compliance:

    Time frame: 24 hours

    Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%

Secondary outcomes

  1. Avoidance of SpO2 Extremes:

    Time frame: 24 hours

    Percent-Time with SpO2 a) <80% and b) with >98% SpO2 with FiO2>21%

Sponsors and collaborators

Lead sponsor

Vyaire Medical

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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