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

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848755
• Other study ID #: 2016-Cr-USG-1
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 9, 2018

Study information

• Verified date: June 2018
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: June 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Weeks

Eligibility

Inclusion Criteria:

• both gender

• <1500 gr <32 week-

• 1-28 days neonates

Exclusion Criteria:

• Anomalies and no viability

Related Conditions & MeSH terms

• Birth Weight
• Infant, Premature

Intervention

Device:
• Cranial ultrasonography

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak NICU	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Epub 2005 Jun 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurements of ventricular indexes of preterm infants	measuring distance with 2D USG	12 months
Primary	measurements of brain volumes of preterm infants	subtracting the ventricular volumes from the total brain volume measured with 2D	12 months