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Clinical Trials/NCT03553134
NCT03553134
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country41 target enrollmentApril 19, 2018
ConditionsNewborn

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Newborn
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
41
Locations
1
Primary Endpoint
Right and left average velocity of the cerebral artery
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 19, 2018
End Date
October 25, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • 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)

Outcomes

Primary Outcomes

Right and left average velocity of the cerebral artery

Time Frame: Change from birth to 48 hours of life

Study Sites (1)

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