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Completed

NCT Number: NCT03553134

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

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.

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Key information

Conditions

Newborn

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Right and left average velocity of the cerebral artery

    Time frame: Change from birth to 48 hours of life

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: VELOCITE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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