Ultrasound Imaging of the Subarachnoidal Space at the Lumbar Region in Preterm and Term Newborn Infants

Szeged University1 site in 1 country2,000 target enrollmentMay 1, 2019

ConditionsUltrasound Newborn Infant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ultrasound
Sponsor: Szeged University
Enrollment: 2000
Locations: 1
Primary Endpoint: Normal lumbal CSF index in neonates
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

January 1, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Szeged University

Responsible Party

Principal Investigator

Judit Mari

assistant lecturer

Szeged University

Eligibility Criteria

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)