Infant/ Neonate Lumbar PunctureNCT02193763
Bedside Ultrasound Assisted Pediatric Lumbar Puncture
A study testing Ultrasound assisted lumbar puncture in people with Infant/ Neonate Lumbar Puncture, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Infant/ Neonate Lumbar Puncture
- What is being tested?
- Ultrasound assisted lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study
Who cannot join
- previous back surgeries
- parent/ guardian inability to understand informed consent
- parent/guardian refusal of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
About this study
Official title: Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
Read the detailed description
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture
- Conditions
- Infant/ Neonate Lumbar Puncture
- Being tested
- Ultrasound assisted lumbar puncture
- Keywords
- pediatric, lumbar puncture, ultrasonography, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assisted lumbar punctureProcedure or surgery
Also called Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer, or, Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
| Study group | Role | What they receive |
|---|---|---|
| 90 days and under--Interventional | Experimental | Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture Receives: Procedure: Ultrasound assisted lumbar puncture |
| 90 days and under--control | No intervention | Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach |
| Over 90 days--Interventional | Experimental | Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture Receives: Procedure: Ultrasound assisted lumbar puncture |
| Over 90 days--Control | No intervention | Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic lumbar puncture
RBC>10,000/ mm3 on spinal fluid analysis
Measured: up to 24 hours
Unsuccessful lumbar puncture
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
Measured: average of <1hour
Secondary outcomes (1)
Hospital length of stay
as reported in the subjects' medical record
Measured: average of <7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startAug 2009
- Primary completionJun 2024
- Study completionJun 2024
Why it stopped: PI has relocated to another institution, no other site PI to take over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant/ Neonate Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Lam, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193763
- Sponsor's protocol ID
- AHC 4746
- Status last verified
- Jun 2024
- First submitted
- 13 Jul 2014
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02193763
- Acronym / sponsor ID
- AHC 4746
- Conditions
- Infant/ Neonate Lumbar Puncture
- Keywords
- pediatric, lumbar puncture, ultrasonography, efficacy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has relocated to another institution, no other site PI to take over
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2024 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
Detailed description
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 90 days and under--Interventional | Experimental | Procedure: Ultrasound assisted lumbar punctureNeonates aged 90 days and under randomized to ultrasound assisted lumbar puncture |
| 90 days and under--control | No intervention | –Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach |
| Over 90 days--Interventional | Experimental | Procedure: Ultrasound assisted lumbar punctureNeonates aged over 90 days randomized to ultrasound assisted lumbar puncture |
| Over 90 days--Control | No intervention | –Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study
Key exclusion criteria (3 listed)
- previous back surgeries
- parent/ guardian inability to understand informed consent
- parent/guardian refusal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound assisted lumbar punctureAlso: Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer, or, Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings. | Procedure or surgery | 90 days and under--Interventional, Over 90 days--Interventional |
Primary outcome
Traumatic lumbar puncture
Time frame: up to 24 hours
RBC>10,000/ mm3 on spinal fluid analysis
Unsuccessful lumbar puncture
Time frame: average of <1hour
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
1 secondary outcome
Hospital length of stay
Time frame: average of <7days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Lam, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound assisted lumbar puncture in people with Infant/ Neonate Lumbar Puncture, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic lumbar puncture (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.