Ultrasound Imaging of Subarachnoidal Space in Newborn Infants

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04004130

Enrollment

2000

Registered

2019-07-01

Start date

2019-05-01

Completion date

2021-01-01

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Infant, Ultrasound

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.

Interventions

OTHERUltrasound imaging

Ultrasound imaging of the lumbar spine/subarachnoidal space

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 7 Days

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Hungary

Contacts

Primary ContactJudit Mari, MD

mari.judit@med.u-szeged.hu+36302381420

Backup ContactTímea Füzesi

office.pedia@med.u-szeged.hu+3662545330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026