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Comparison of Oxygen Controllers in Preterm InfanTs

NCT03877198 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-06-09

No results posted yet for this study

Summary

Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

Conditions

  • Premature Infant
  • Respiratory Insufficiency
  • Hypoxia
  • Hyperoxia

Interventions

DEVICE

Automated oxygen control by the CLiO2 algorithm

Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period

DEVICE

Automated oxygen control by the Oxygenie algorithm

Automated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period.

Sponsors & Collaborators

  • University of Tasmania

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Arjan B te Pas, Prof · Leiden University Medical Center

  • Peter A Dargaville, Prof · University of Tasmania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2020-02-13
Completion
2020-02-13

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877198 on ClinicalTrials.gov