NCT04004130

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

June 27, 2019

Last Update Submit

June 27, 2019

Conditions

UltrasoundNewborn Infant

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Ultrasound imagingOTHER

Ultrasound imaging of the lumbar spine/subarachnoidal space

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szeged University, Department of Paediatrics

Szeged, 6720, Hungary

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Judit Mari, MD

CONTACT

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

Tímea Füzesi

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

May 1, 2019

Primary Completion

September 30, 2020

Study Completion

January 1, 2021

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

HU(1)