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

NCT03553134 | Completed

• 1 other identifier: LITZLER-RENAULT 2018 VELOCITE
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn

Outcome Measures

Primary Outcomes (1)

• Right and left average velocity of the cerebral artery

  Change from birth to 48 hours of life

Interventions

transcranial doppler ultrasound scan DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns over 35 weeks of amenorrhoea

You may qualify if:

• Written consent of parent
• Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: April 19, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

FR (1)