NCT02815618

Brief Summary

Feasibility trial on the use of a hybrid optical device integrating time-resolved near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement of cerebral oxygen metabolism and blood flow in neonates. The device wil be tested in four settings measuring:

  1. 1.Changes in cerebral oxygenation and haemodynamics after birth
  2. 2.precision and repeatability
  3. 3.The cerebral vaso-reactivity to arterial carbon dioxide
  4. 4.Assessment of the user-friendliness and loss of signal in routine care

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

June 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

June 23, 2016

Last Update Submit

March 27, 2023

Conditions

Hemodynamic Instability

Keywords

Time-resolved spectroscopyDiffuse correlation spectroscopyNeonatology

Outcome Measures

Primary Outcomes (4)

  • Cerebral tissue oxygen saturation (StO2) after birth.

    Measurement of cerebral haemodynamics immediately after birth.

    10 min immediately after umbilical cord clamping.

  • Precision and repeatability

    Test-retest variability estimated by within-subject standard deviation in one-way ANOVA with subject as factor.

    During second day of life.

  • Cerebral vaso-reactivity to arterial carbon dioxide

    Mean CBFi and tcpCO2 one minute before the change and 15 min after will be used to analyse CBFi-tcpCO2 reactivity.

    1 hour after change in ventilator settings.

  • Assessment of user-friendliness and loss of signal in routine care

    Assessed by Likert-scale questionnaire completed by clinical staff.

    24 hours of contineous measurements.

Study Arms (3)

Infants delivered by elective caesarean

Infants to be measured immediately after birth and on their second day of life.

Device: BabyLux Neuro-monitor

Infants on mechanical ventilation

Infants to be measured while changing ventilator settings to normalize arterial pCO2.

Device: BabyLux Neuro-monitor

Infants on ventilatory support

Infants to be measured for 24 hours continuously to assess user-friendliness and loss of signal.

Device: BabyLux Neuro-monitor

Interventions

BabyLux Neuro-monitorDEVICE

Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).

Infants delivered by elective caesareanInfants on mechanical ventilationInfants on ventilatory support

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Setting 1 and 2: Newborn infants immediately after delivery by elective caesarean and on their second day of life. Setting 3: Premature infants on mechanical ventilation. Setting 4: Neonate infants on ventilatory support

You may qualify if:

  • GA \> 37 weeks
  • planned to be delivered by an uncomplicated elective caesarean section

You may not qualify if:

  • need for resuscitation or supplementary oxygen during the first 10 minutes following umbilical cord clamping
  • congenital malformations
  • Setting 3:
  • GA \< 37 weeks
  • Postnatal age more \> 24 hours
  • Mechanically ventilated
  • Clinically stable
  • Normal brain ultrasound
  • Transcutaneous pCO2 monitoring (tcpCO2)
  • Congenital malformations
  • Setting 4:
  • Postnatal age \< 28 days
  • ventilatory support by mechanical ventilation or nasal CPAP
  • Congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (1)

  • De Carli A, Andresen B, Giovannella M, Durduran T, Contini D, Spinelli L, Weigel UM, Passera S, Pesenti N, Mosca F, Torricelli A, Fumagalli M, Greisen G. Cerebral oxygenation and blood flow in term infants during postnatal transition: BabyLux project. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F648-F653. doi: 10.1136/archdischild-2018-316400. Epub 2019 May 13.

    PMID: 31085677DERIVED

Related Links

Study Officials

  • Gorm Greisen, MD, Prof.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2021

Study Completion

December 1, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

IT(1)DK(1)