The feasibility and safety of the use of automated oxygen in babies admitted to the neonatal intensive care unit

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47204932

Enrollment

Registered

2021-10-28

Start date

2016-09-27

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Preterm newborns with oxygen requirement Respiratory

Interventions

Newborns on respiratory support requiring oxygen wil be subjected to an 8 hour study period of automated control of oxygen with the PRICO algorithm that is used to control O2 on the Fabian HFO ventila

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newborns receiving respiratory support and a FiO2 moor than 21% while having an FiO2 of 95% or less and no plans to chnage ventilation mode during the next 24 hours

Exclusion criteria

Exclusion criteria: 1. Major congenital of chromosomal defects 2. Plans to transfer the patient out within 24 hours 3. Plans to change ventilation mode within 24 hours

Design outcomes

Primary

Measure	Time frame
Time spent within the SpO2 target range measured using a pulse oximeter and logged at 1/s interval both during the study and during the control periods	—

Secondary

Measure	Time frame
Time spent below target range, time spent above target range, average FiO2 and SpO2 measured using a pulse oximeter and logged at 1/s interval both during the study and during the control periods	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026