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

NCT02848755 | Completed

• 1 other identifier: 2016-Cr-USG-1
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (2)

• measurements of ventricular indexes of preterm infants

  measuring distance with 2D USG

  12 months

• measurements of brain volumes of preterm infants

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

  12 months

Interventions

Cranial ultrasonography DEVICE

Eligibility Criteria

• Age: 1 Day - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All NICU preterm infants under 1500 gr

You may qualify if:

• both gender
• \<1500 gr \<32 week-
• days neonates

You may not qualify if:

• Anomalies and no viability

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator

Study Sites (1)

Zekai Tahir Burak NICU

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15956095 BACKGROUND

• 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.

  PMID: 33175184 DERIVED

• 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.

  PMID: 31853896 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fuat Emre Canpolat

  Zekai Tahir Burak Hospital NICU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uzm Dr

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: July 28, 2016
• Study Start: January 1, 2017
• Primary Completion: May 9, 2018
• Study Completion: June 9, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)