Randomized evaluation of two SpO2 alarm strategies during ventilation with automated oxygen supply control in the NICU

Randomized evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN49239883

Enrollment

Registered

2018-05-15

Start date

2016-06-27

Completion date

Unknown

Last updated

2019-05-27

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

Conditions

Newborn babies with respiratory failure ventilated in NICU with AVEA CLiO2 ventilator Neonatal Diseases

Interventions

The study will compare two oxygenation alarm strategies, starting on the first day of life and ending with a transition in respiratory support or at 6 days, whichever occurred first. The tight strate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants with respiratory failure ventilated and with need of oxygen

Exclusion criteria

Exclusion criteria: 1. 6 days of intervention 2. Clinical exacerbation 3. Weaned from AVEA-CLiO 4. Withdrawn consent

Design outcomes

Primary

Measure	Time frame
The relative frequency and duration of audible alarms, collected with a datalogger plugged in to the ventilator throughout the study	—

Secondary

Measure	Time frame
The prevalence of SpO2 associated with hyperoxemia and hypoxemia, collected with a datalogger plugged in to the ventilator throughout the study	—

Countries

Poland

Outcome results

None listed

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