Ultrasound Imaging of Subarachnoidal Space in Newborn Infants

Not Applicable

• Conditions: Ultrasound; Newborn Infant

• Registration Number: NCT04004130
• Lead Sponsor: Szeged University

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.

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Last Update Submitted: 2019-06-27
• Study First Posted: 2019-07-01
• Last Update Posted: 2019-07-01
• Primary Completion: 2020-09-30
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Normal lumbal CSF index in neonates	From Day 1 to Day 7	Normal range (amount/ratio) of CSF in neonates, influencing the following factors: gestational age, postnatal age, fluid intake, type of delivery.

Trial Locations

Locations (1)

Szeged University, Department of Paediatrics; 🇭🇺 Szeged, Hungary