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

NCT ID: NCT03553134

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-19

Study Completion Date

2018-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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transcranial doppler ultrasound scan

Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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LITZLER-RENAULT 2018 VELOCITE

Identifier Type: -

Identifier Source: org_study_id

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