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OpenTrials
Completed

NCT Number: NCT02848755

Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography

Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.

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Key information

Age range

1 day–40 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Zekai Tahir Burak NICU

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • both gender
  • <1500 gr <32 week-
  • 1-28 days neonates

Exclusion criteria

  • Anomalies and no viability

Treatment and study plan

Cranial ultrasonography

Device

Primary outcomes

  1. measurements of ventricular indexes of preterm infants

    Time frame: 12 months

    measuring distance with 2D USG

  2. measurements of brain volumes of preterm infants

    Time frame: 12 months

    subtracting the ventricular volumes from the total brain volume measured with 2D

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Collaborators

  • Netherlands: Ministry of Health, Welfare and Sports

Registry information

Official study title

Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2016
Registry last updated
Jun 15, 2018

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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