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Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward (VELOCITE)

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ClinicalTrials.gov Identifier: NCT03553134
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.

Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.

The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.


Condition or disease Intervention/treatment
Newborn Diagnostic Test: transcranial doppler ultrasound scan Diagnostic Test: ultrasound scan centered on the arterial canal

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Intervention Details:
  • Diagnostic Test: transcranial doppler ultrasound scan
    Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)
  • Diagnostic Test: ultrasound scan centered on the arterial canal
    Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)


Primary Outcome Measures :
  1. Right and left average velocity of the cerebral artery [ Time Frame: Change from birth to 48 hours of life ]


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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newborns over 35 weeks of amenorrhoea
Criteria

Inclusion Criteria:

  • Written consent of parent
  • Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward

Exclusion Criteria:

  • person not affiliated to a health insurance scheme
  • Sepsis
  • Ductal dependent heart disease
  • Neurological impairment (anoxoischemic encephalopathy Sarnat>1, pH<7 and/or lactates>11, meningitis)
  • Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
  • Potentially lethal malformation
  • Anemia (hemoglobin<14g/dl)
  • Polyglobulia (hemoglobin>22g/dl)
  • Small for gestational age (weight<10th percentile)
  • Large for gestational age (weight>97th percentile)
  • Proven gestational diabetes (non-insulin-dependent and insulin-dependent)
  • Maternal medical treatment (cardiac or anti-epileptic)
  • Inadequate parent understanding

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): NCT03553134


Locations
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France
Chu Dijon Bourogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03553134     History of Changes
Other Study ID Numbers: LITZLER-RENAULT 2018 VELOCITE
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No