Comparison of Oxygen Controllers in Preterm InfanTs

NCT03877198 | Terminated

• 2 other identifiers: COCkPITNL66058.000.18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of time with SpO2 spent within set target range

  Total time SpO2 is within the set target range (91-95%) including time spent above target range when in room air (set FiO2 \< 0.22)

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

Secondary Outcomes (13)

• Proportion of time with SpO2 spent above target range (SpO2 > 95%)

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

• Proportion of time with SpO2 spent below target range (SpO2 < 91%)

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

• Coefficient of SpO2 variation

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

• Time in hypoxemic SpO2 ranges

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

• Time in hyperoxemic SpO2 ranges

  Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.

Study Arms (2)

CLiO2

EXPERIMENTAL

Automated oxygen control by the CLiO2 algorithm

Device: Automated oxygen control by the CLiO2 algorithm

Oxygenie

EXPERIMENTAL

Automated oxygen control by the Oxygenie algorithm

Device: Automated oxygen control by the Oxygenie algorithm

Interventions

Automated oxygen control by the CLiO2 algorithm DEVICE

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

Also known as: AVEA CLiO2

CLiO2

Automated oxygen control by the Oxygenie algorithm DEVICE

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

Also known as: SLE Oxygenie

Oxygenie

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
• Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
• Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
• Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
• Written informed parental consent must be present.

You may not qualify if:

• Major congenital anomalies
• Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
• If the attending physician considers the infant not stable enough for a switch to another ventilator.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• University of Tasmania: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333, Netherlands

Location

Related Publications (1)

• Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.

  PMID: 34112721 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Insufficiency; Hypoxia; Hyperoxia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arjan B te Pas, Prof

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter A Dargaville, Prof

  University of Tasmania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor/investigator will be blinded for treatment allocation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Pediatrics

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: February 19, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

NL (1)