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

June 13, 2018 updated by: Gulsum Kadioğlu Simsek, Zekai Tahir Burak Women's Health Research and Education Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

341

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Zekai Tahir Burak NICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All NICU preterm infants under 1500 gr

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Anomalies and no viability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurements of ventricular indexes of preterm infants
Time Frame: 12 months
measuring distance with 2D USG
12 months
measurements of brain volumes of preterm infants
Time Frame: 12 months
subtracting the ventricular volumes from the total brain volume measured with 2D
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Investigators

  • Principal Investigator: Fuat Emre Canpolat, Zekai Tahir Burak Hospital NICU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 9, 2018

Study Completion (Actual)

June 9, 2018

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-Cr-USG-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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