Comparison of Brain Volumes Measured by 2D USG and MRI

Central Nervous System Vulnerabilities in Preterm Infants Clinical Trial

Official title:

Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190017
• Other study ID #: 2019512-1
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: January 2021
• Source: Ankara City Hospital Bilkent
• Contact: FUAT EMRE CANPOLAT, MD
• Phone: 05055668716
• Email: femrecan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.

Description:

All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams

• Born in our hospital

• Alive during discharge

Exclusion Criteria:

• congenital anomalies

• cranial bleeding

• early death

Related Conditions & MeSH terms

• Central Nervous System Vulnerabilities in Preterm Infants
• Premature Birth

Intervention

Other:
• Cranial MRI
Cranial MRI

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Benavente-Fernandez I, Lubián-Gutierrez M, Jimenez-Gomez G, Lechuga-Sancho AM, Lubián-López SP; Neonatal Neurology Foundation (Fundación Nene). Ultrasound lineal measurements predict ventricular volume in posthaemorrhagic ventricular dilatation in preterm infants. Acta Paediatr. 2017 Feb;106(2):211-217. doi: 10.1111/apa.13645. Epub 2016 Nov 21. — View Citation

Cheong JL, Thompson DK, Spittle AJ, Potter CR, Walsh JM, Burnett AC, Lee KJ, Chen J, Beare R, Matthews LG, Hunt RW, Anderson PJ, Doyle LW. Brain Volumes at Term-Equivalent Age Are Associated with 2-Year Neurodevelopment in Moderate and Late Preterm Children. J Pediatr. 2016 Jul;174:91-97.e1. doi: 10.1016/j.jpeds.2016.04.002. Epub 2016 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of two different brain volumes	Patients in cohort will have both USG and cranial MRI	6 months