NCT04004130

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Szeged University · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Ultrasound
• Newborn Infant

Interventions

Type	Name	Description
OTHER	Ultrasound imaging	Ultrasound imaging of the lumbar spine/subarachnoidal space

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-09-30
• Completion: 2021-01-01
• First posted: 2019-07-01
• Last updated: 2019-07-01

Locations

1 site across 1 country: Hungary