NCT03785899

Brief Summary

Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by automatic control (SPOC) with "old"-algorithm and RMC supported by CLAC with "new"-algorithm. The first primary hypothesis is, that the use of the "new" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the new algorithm results in more time within SpO2 target range compared to SPOCold. The second primary hypothesis is, that the use of 2 seconds averaging time of the SpO2 Signal results in more time within arterial oxygen saturation (SpO2) target range compared to the use of 8 seconds averaging interval of the SpO2 signal.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 4, 2019

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

December 20, 2018

Last Update Submit

January 2, 2019

Conditions

Infantile Respiratory Distress SyndromeVentilator Lung; Newborn

Outcome Measures

Primary Outcomes (1)

  • Proportion of time with SpO2 within target range

    Comparison of proportion of time with SpO2 within target range and time above target range if no supplemental oxygen was administered at that time and within the preceding 30sec between the five treatment modalities

    30 hours

Secondary Outcomes (6)

  • Proportion of Time with SpO2 above target range

    30 hours

  • Proportion of Time with SpO2 below target range

    30 hours

  • Proportion of Time with Hypoxia

    30 hours

  • Proportion of Time with Hyperoxia

    30 hours

  • Stability of cerebral oxygenation

    30 hours

  • +1 more secondary outcomes

Other Outcomes (2)

  • Staff workload

    30 hours

  • Validation of clinical Apnea Score

    30 hours

Study Arms (5)

RMC only

NO INTERVENTION

routine manual control (RMC) of the fraction of inspired oxygen (FIO2)

SPOCnew and 2s SpO2 averaging

EXPERIMENTAL

routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s.

Device: SPOCnewDevice: 2s SpO2 averaging

SPOCnew and 8s SpO2 averaging

EXPERIMENTAL

routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s.

Device: SPOCnewDevice: 8s SpO2 averaging

SPOCold and 2s SpO2 averaging

ACTIVE COMPARATOR

routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s.

Device: SPOColdDevice: 2s SpO2 averaging

SPOCold and 8s SpO2 averaging

ACTIVE COMPARATOR

routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s.

Device: 8s SpO2 averagingDevice: SPOCold

Interventions

SPOCnewDEVICE

SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised "new" algorithm is turned on.

SPOCnew and 2s SpO2 averagingSPOCnew and 8s SpO2 averaging
8s SpO2 averagingDEVICE

The arterial saturation (SPO2) will be averaged over 8s.

SPOCnew and 8s SpO2 averagingSPOCold and 8s SpO2 averaging
SPOColdDEVICE

SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former "old" algorithm is turned on.

SPOCold and 2s SpO2 averagingSPOCold and 8s SpO2 averaging
2s SpO2 averagingDEVICE

The arterial saturation (SPO2) will be averaged over 2s.

SPOCnew and 2s SpO2 averagingSPOCold and 2s SpO2 averaging

Eligibility Criteria

AgeUp to 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • gestational age at birth \<34+1/7weeks and
  • invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and
  • parental written informed consent

You may not qualify if:

  • congenital pulmonary anomalies
  • congenital heart defects influencing SpO2 (i.e. cyanotic heart defects)
  • right-to -left shunt through a PDA
  • Severe neonatal complications during study period (sepsis, necrotising enterocolitis)
  • diaphragmatic hernia or other diaphragmatic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology, University Children's Hospital

Tübingen, 72076, Germany

RECRUITING

Related Publications (2)

  • Langanky LO, Kreutzer KB, Poets CF, Franz AR, Schwarz CE. Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control. Eur J Pediatr. 2024 Jul;183(7):2865-2869. doi: 10.1007/s00431-024-05549-9. Epub 2024 Apr 9.

    PMID: 38592485DERIVED

  • Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O'Sullivan MP, Poets CF, Franz AR. Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):425-430. doi: 10.1136/archdischild-2021-322096. Epub 2021 Nov 24.

    PMID: 34819347DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornBronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentilator-Induced Lung InjuryLung Injury

Study Officials

  • Christoph E Schwarz, MD

    University of Tubingen, University Hospital, Dept. Neonatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph E Schwarz, MD

CONTACT

+49707129-0c.schwarz@med.uni-tuebingen.de

Axel R Franz, MD

CONTACT

+49707129-0axel.franz@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

August 3, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

January 4, 2019

Record last verified: 2018-08

Locations

DE(1)