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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03553134
Acronym
VELOCITE
Enrollment
41
Registered
2018-06-12
Start date
2018-04-19
Completion date
2018-10-25
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn

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.

Interventions

DIAGNOSTIC_TESTtranscranial doppler ultrasound scan

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

DIAGNOSTIC_TESTultrasound scan centered on the arterial canal

Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Right and left average velocity of the cerebral arteryChange from birth to 48 hours of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026