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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2019
Source Szeged University
Contact Judit Mari, MD
Phone +36302381420
Email mari.judit@med.u-szeged.hu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Based on the available literature the success rate of neonatal lumbar puncture (LP) is quite low (some articles reporting as low as 50% (unsuccessful LPs including dry taps and traumatic taps)).

Firstly, the investigators would like to set a normal range of CSF:spine ratio (representing the amount of CSF at the expected level of LP) based on the measurements in neonates of different gestational age and postnatal age with assessing ventricular index (VI) on cranial US.

In the next phase of the study the investigators plan to assess the subarachnoidal space/amount of CSF of those neonates whom need LP performed. The investigators hypothise to be able to create an ultrasound measurement index/number that would be able to predict unsuccessful LPs.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound imaging
Ultrasound imaging of the lumbar spine/subarachnoidal space

Locations

Country Name City State
Hungary Szeged University, Department of Paediatrics Szeged

Sponsors (2)

Lead Sponsor Collaborator
Szeged University Affidea Magyarország

Country where clinical trial is conducted

Hungary, 

Outcome

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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