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

Newborn Clinical Trial

— VELOCITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553134
• Other study ID #: LITZLER-RENAULT 2018 VELOCITE
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: September 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Newborn

Intervention

Diagnostic Test:
• transcranial doppler ultrasound scan
Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)
• 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)

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right and left average velocity of the cerebral artery		Change from birth to 48 hours of life