Ultrasound Clinical Trial
Official title:
Ultrasound Imaging of the Subarachnoidal Space at the Lumbar Region in Preterm and Term Newborn Infants
NCT number | NCT04004130 |
Other study ID # | 207/2018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | January 1, 2021 |
Based on the ultrasound measurement of CSF/spinal cord ratio in neonates the investigators plan to define a normal range of CSF volume for 0-7 day old newborns. The investigators hypothise to be able to create an ultrasound measurement index/number to predict unsuccessful neonatalal LPs.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | January 1, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: All neonates born at the Obstretrics and Gynecology Department,
University of Szeged and all treated neonates at the Neonatal Unit, Pediatric Department,
University of Szeged Exclusion Criteria: Hemidynamical instability, Strict minimal handling (eg Pulmonary Hypertension, MAS etc), Total Body Coooling for HIE (Hypoxic Ischemic Encephalopathy) |
Country | Name | City | State |
---|---|---|---|
Hungary | Szeged University, Department of Paediatrics | Szeged |
Lead Sponsor | Collaborator |
---|---|
Szeged University | Affidea Magyarország |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normal lumbal CSF index in neonates | Normal range (amount/ratio) of CSF in neonates, influencing the following factors: gestational age, postnatal age, fluid intake, type of delivery. | From Day 1 to Day 7 |
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