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An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology (BabyLux)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02815618
Recruitment Status : Active, not recruiting
First Posted : June 28, 2016
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment
Hemodynamic Instability Device: BabyLux Neuro-monitor

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology
Study Start Date : June 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Infants delivered by elective caesarean
Infants to be measured immediately after birth and on their second day of life.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).

Infants on mechanical ventilation
Infants to be measured while changing ventilator settings to normalize arterial pCO2.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).

Infants on ventilatory support
Infants to be measured for 24 hours continuously to assess user-friendliness and loss of signal.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).




Primary Outcome Measures :
  1. Cerebral tissue oxygen saturation (StO2) after birth. [ Time Frame: 10 min immediately after umbilical cord clamping. ]
    Measurement of cerebral haemodynamics immediately after birth.

  2. Precision and repeatability [ Time Frame: During second day of life. ]
    Test-retest variability estimated by within-subject standard deviation in one-way ANOVA with subject as factor.

  3. Cerebral vaso-reactivity to arterial carbon dioxide [ Time Frame: 1 hour after change in ventilator settings. ]
    Mean CBFi and tcpCO2 one minute before the change and 15 min after will be used to analyse CBFi-tcpCO2 reactivity.

  4. Assessment of user-friendliness and loss of signal in routine care [ Time Frame: 24 hours of contineous measurements. ]
    Assessed by Likert-scale questionnaire completed by clinical staff.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Setting 1 and 2:

Inclusion Criteria:

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

Exclusion Criteria:

  • need for resuscitation or supplementary oxygen during the first 10 minutes following umbilical cord clamping
  • congenital malformations

Setting 3:

Inclusion Criteria:

  • GA < 37 weeks
  • Postnatal age more > 24 hours
  • Mechanically ventilated
  • Clinically stable
  • Normal brain ultrasound
  • Transcutaneous pCO2 monitoring (tcpCO2)

Exclusion Criteria:

  • Congenital malformations

Setting 4:

Inclusion Criteria:

  • Postnatal age < 28 days
  • ventilatory support by mechanical ventilation or nasal CPAP

Exclusion Criteria:

  • Congenital malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815618


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Italy
IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
Gorm Greisen
Investigators
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Principal Investigator: Gorm Greisen, MD, Prof. Rigshospitalet, Denmark
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gorm Greisen, Professor, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02815618    
Other Study ID Numbers: BabyLux CIP 4.1
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
Time-resolved spectroscopy
Diffuse correlation spectroscopy
Neonatology