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

NCT ID: NCT02848755

Last Updated: 2018-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

341 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-06-09

Brief Summary

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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.

Detailed Description

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Conditions

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Infant, Premature

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cranial ultrasonography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Anomalies and no viability
Minimum Eligible Age

1 Day

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands: Ministry of Health, Welfare and Sports

OTHER_GOV

Sponsor Role collaborator

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gulsum Kadioğlu Simsek

Uzm Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fuat Emre Canpolat

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Hospital NICU

Locations

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Zekai Tahir Burak NICU

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Rademaker KJ, Uiterwaal CS, Beek FJ, van Haastert IC, Lieftink AF, Groenendaal F, Grobbee DE, de Vries LS. Neonatal cranial ultrasound versus MRI and neurodevelopmental outcome at school age in children born preterm. Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F489-93. doi: 10.1136/adc.2005.073908. Epub 2005 Jun 14.

Reference Type BACKGROUND
PMID: 15956095 (View on PubMed)

Isik S, Buyuktiryaki M, Simsek GK, Kutman HGK, Canpolat FE. Relationship between biparietal diameter/ventricular ratio and neurodevelopmental outcomes in non-handicapped very preterm infants. Childs Nerv Syst. 2021 Apr;37(4):1121-1126. doi: 10.1007/s00381-020-04960-5. Epub 2020 Nov 11.

Reference Type DERIVED
PMID: 33175184 (View on PubMed)

Simsek GK, Canpolat FE, Buyuktiryaki M, Okman E, Keser M, Ustunyurt Z, Kutman HGK. Developmental outcomes of very low birthweight infants with non-hemorrhagic ventricular dilatations and the relationships thereof with absolute brain volumes measured via two-dimensional ultrasonography. Childs Nerv Syst. 2020 Jun;36(6):1231-1237. doi: 10.1007/s00381-019-04464-x. Epub 2019 Dec 18.

Reference Type DERIVED
PMID: 31853896 (View on PubMed)

Other Identifiers

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2016-Cr-USG-1

Identifier Type: -

Identifier Source: org_study_id

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