NCT03877198: COCkPIT

Comparison of Oxygen Controllers in Preterm InfanTs

Terminated NA Last updated 9 June 2020

What this trial tests

NA trial testing Automated oxygen control by the CLiO2 algorithm in Premature Infant in 15 participants. Terminated before completion.

Timeline

19 February 2019

Primary endpoint
13 February 2020

13 February 2020

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	15
Start date	19 February 2019
Primary completion	13 February 2020
Estimated completion	13 February 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Automated oxygen control by the CLiO2 algorithm
• Automated oxygen control by the Oxygenie algorithm

Conditions studied

• Premature Infant — all drugs for Premature Infant →
• Respiratory Insufficiency — all drugs for Respiratory Insufficiency →
• Hypoxia — all drugs for Hypoxia →
• Hyperoxia — all drugs for Hyperoxia →

Sponsor

Leiden University Medical Center

Who can join

Under 8 Weeks, any sex, with Premature Infant or Respiratory Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial.
   Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, et al · · 2022 · cited 14× · PMID 34112721 · DOI 10.1136/archdischild-2020-321387
2. Automated oxygen delivery for preterm infants with respiratory dysfunction.
   Stafford IG, Lai NM, Tan K. · · 2023 · cited 13× · PMID 38032241 · DOI 10.1002/14651858.cd013294.pub2