Clinical trial NCT02848755: Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Official title: Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2016-07-28
Enrollment: 341
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All NICU preterm infants under 1500 gr

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Anomalies and no viability

Primary outcomes:
measure: measurements of ventricular indexes of preterm infants
timeFrame: 12 months
measure: measurements of brain volumes of preterm infants
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak NICU
Study officials:
affiliation: Zekai Tahir Burak Hospital NICU
name: Fuat Emre Canpolat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.