Infant, Premature Clinical Trial
Official title:
Neonatal Cranial Ultrasonography for Measuring Brain Volumes of Very Low Birth Weight Infants
NCT number | NCT02848755 |
Other study ID # | 2016-Cr-USG-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | June 9, 2018 |
Verified date | June 2018 |
Source | Zekai Tahir Burak Women's Health Research and Education Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zekai Tahir Burak NICU | Ankara |
Lead Sponsor | Collaborator |
---|---|
Zekai Tahir Burak Women's Health Research and Education Hospital | Netherlands: Ministry of Health, Welfare and Sports |
Turkey,
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
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 |
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