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

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.

Study Overview

• Status: Completed
• Conditions: Newborn
• Intervention / Treatment: Diagnostic test: transcranial doppler ultrasound scan; Diagnostic test: ultrasound scan centered on the arterial canal

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborns over 35 weeks of amenorrhoea

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Right and left average velocity of the cerebral artery	Change from birth to 48 hours of life

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2018
• Primary Completion (ACTUAL): October 25, 2018
• Study Completion (ACTUAL): October 25, 2018

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: LITZLER-RENAULT 2018 VELOCITE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No