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

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ClinicalTrials.gov Identifier: NCT02848755
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Gulsum Kadioğlu Simsek, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Infant, Premature Device: Cranial ultrasonography

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Study Type : Observational
Actual Enrollment : 341 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : June 9, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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



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Ages Eligible for Study:   up to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All NICU preterm infants under 1500 gr
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Anomalies and no viability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848755


Locations
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Turkey
Zekai Tahir Burak NICU
Ankara, Turkey
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Netherlands: Ministry of Health, Welfare and Sports
Investigators
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Principal Investigator: Fuat Emre Canpolat Zekai Tahir Burak Hospital NICU

Publications:
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Responsible Party: Gulsum Kadioğlu Simsek, Uzm Dr, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02848755     History of Changes
Other Study ID Numbers: 2016-Cr-USG-1
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms