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Spinal cord Position in Neonates At Lumbar puncture (SPINAL)

Interobserver variability of clinician performed ultrasound to assess the spinal cord termination in neonates

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000758101
Acronym
SPINE
Enrollment
40
Registered
2019-05-22
Start date
2019-08-01
Completion date
2020-01-01
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

Aim: To determine the interobserver variability of ultrasound of the spinal cord performed on infants by clinicians. Hypothesis: We hypothesise that clinician performed ultrasound reliably and reproducibly identifies the end of the spinal cord in newborn infants. If reliable, the use of spinal ultrasound would enhance the safety of infants undergoing lumbar puncture by ensuring that the location of puncture occurs below the end of the spinal cord thus eliminating the risk of cord injury.

Interventions

The participants will be infants admitted to the hospital who require lumbar puncture. There are no exclusions. The spinal cord will be examined by ultrasound using linear array probe in mid sagittal (up and down the body) and transverse planes (across the body) and location of the termination of the spinal cord defined in relation to surrounding vertebral bodies. Ultrasound examinations will be performed by 2 practitioners, Neonatal Consultants or Senior Neonatal Trainees who are experienced

The participants will be infants admitted to the hospital who require lumbar puncture. There are no exclusions. The spinal cord will be examined by ultrasound using linear array probe in mid sagittal (up and down the body) and transverse planes (across the body) and location of the termination of the spinal cord defined in relation to surrounding vertebral bodies. Ultrasound examinations will be performed by 2 practitioners, Neonatal Consultants or Senior Neonatal Trainees who are experienced in the use of ultrasound. They will have training in the method for examination of the spine and will be allowed to familiarise themselves with this technique. The procedure will be performed twice by the first observer and twice by a second observer who is blinded to the results of the first. Each observation should take approximately 5 minutes to complete and will occur on the same day.

Sponsors

Lydia Kennedy
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 6 Months
Healthy volunteers
No

Inclusion criteria

The participants will be infants admitted to the hospital who require lumbar puncture.

Exclusion criteria

There are no exclusions.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026