Ultrasound Imaging of Subarachnoidal Space in Newborn Infants

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004130
• Other study ID #: 207/2018
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Newborn Infant
• Ultrasound

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