A randomized cross-over trial in the effect of automated oxygen control devices on the distribution of oxygen saturation in preterm infants

A randomized cross-over trial in the effect of automated oxygen control devices on the distribution of oxygen saturation in preterm infants - Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT))

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45888

Enrollment

Registered

2018-10-18

Start date

2019-02-19

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Respiratory distress ventilation

Interventions

In both groups oxygen will be automatically titrated with the Oxygenie controller and the CLiO2 controller for 25 hours in random sequence. Automated oxygen control is standard care in our unit.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Born between 24 weeks, 0 days and 29 weeks, 6 days of gestation. Receiving invasive mechanical ventilation or non-invasive respiratory support, receiving supplemental oxygen (at least 25%), with written informed parental consent.

Exclusion criteria

Exclusion criteria: Major congenital anomalies, arterial hypotension, if attending physician considers the infant not stable enough for a switch between ventilators.

Design outcomes

Primary

Measure	Time frame
Proportion of time SpO2 spent within set target range (91-95%)	—

Secondary

Measure	Time frame
Time SpO2 spent above target range (SpO2 > 95%). Time SpO2 spent below target range (SpO2 98%), when receiving supplemental oxygen. Frequency of episodes of hypoxaemia (SpO2 30 seconds and >60 seconds. Frequency of episodes of hyperoxaemia (SpO2 >=97% and >=99% when receiving supplemental oxygen). Frequency of episodes of bradycardia (HR	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)