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

Completed

• Conditions: Respiratory Insufficiency in Children

• Registration Number: NCT04957472
• Lead Sponsor: Vyaire Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-6-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Inclusion Criteria:<br><br> - Respiratory insufficiency of infants in the neonatal unit who require respiratory<br> support and supplemental oxygen in one of 4 the therapeutic categories (Intubated<br> HFO, Intubated CMV, Non-Invasive nasal mask, nasal cannula).<br><br> - <30 kg at study entry<br><br> - Informed Consent Form obtained as per EC requirement<br><br>Exclusion Criteria:<br><br> - Not expected to complete 48 hours of the current respiratory support therapeutic<br> category<br><br> - Congenital anomalies<br><br> - Uncontrolled hemodynamics<br><br> - Severe airflow obstruction<br><br> - Intracranial hypertension<br><br> - Start of caffeine therapy within 12 hours<br><br> - Attending physician does not believe participation of the patient is in their best<br> interest.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Range Compliance:

Secondary Outcome Measures

Name	Time	Method
Avoidance of SpO2 Extremes: