Safety and feasability of Predictive Intelligent Control of Oxygenation (PRICO) on the Neonatal Intensive Care Unit (NICU)

Safety and feasability of Predictive Intelligent Control of Oxygenation (PRICO) on the Neonatal Intensive Care Unit (NICU) - PRICO on the NICU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47374

Enrollment

Registered

2016-08-02

Start date

2016-08-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyaline membrane disease respiratory distress syndrome of the newborn under developed lungs

Interventions

Automated control of the FiO2 based on the measured SpO2 during 8 hours.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Neonates who require respiratory support and supplemental oxygen therapy

Exclusion criteria

Exclusion criteria: Planned dismissal or transfer to a other hospital within 24 hours

Design outcomes

Primary

Measure	Time frame
The main parameter during the study is the time the SpO2 spend within the target range.	—

Secondary

Measure	Time frame
Secondary outcomes are the number of hyper and hypoxic events, average maximum and minimum SpO2 during these events, number of FiO2 adjustments (manual and automated) and cerebral oxygen saturation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)