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

Completed

• Conditions: Newborn

• Registration Number: NCT03553134
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right and left average velocity of the cerebral artery	Change from birth to 48 hours of life

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France