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Ultrasound-Assisted Lumbar Puncture for Spinal Tap
N/A
Waitlist Available
Led By Jason Stoller, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neonates and infants aged ≤6 months
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up length of hospitalization (approximately 1 month)
Awards & highlights
Study Summary
This trial will help determine if ultrasound can improve the success rate of a spinal tap.
Who is the study for?
This trial is for neonates and infants up to 6 months old who need a spinal tap, as decided by their doctors. The study team must be available to perform the ultrasound. Babies with recent failed taps, brain bleeding in the last week, spine problems, skin infections at the puncture site or those too unstable can't join.Check my eligibility
What is being tested?
The study is testing if using an ultrasound helps doctors do spinal taps more successfully on babies compared to just feeling for landmarks with hands. It's checking if this new method makes the procedure easier and better.See study design
What are the potential side effects?
Potential side effects may include discomfort during the procedure, bruising or swelling at the puncture site. There might also be risks associated with incorrect needle placement but these are generally rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is 6 months old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ length of hospitalization (approximately 1 month)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~length of hospitalization (approximately 1 month)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of successful first attempt LPs
Secondary outcome measures
Difference in length of antibiotic exposure
Proportion of overall success of LPs within 2 attempts
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ultrasound-Assisted Technique LPExperimental Treatment1 Intervention
Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP
Group II: Palpation Landmark Technique LPExperimental Treatment1 Intervention
Traditional landmark palpation technique will be used to perform LP
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,085 Total Patients Enrolled
Jason Stoller, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is 6 months old or younger.I have an infection where a medical device was inserted into my skin.I was diagnosed with bleeding in my brain less than a week ago.My doctor says I need a lumbar puncture.I have a known spinal cord condition.I had a failed spinal tap attempt in the last 2 days.
Research Study Groups:
This trial has the following groups:- Group 1: Palpation Landmark Technique LP
- Group 2: Ultrasound-Assisted Technique LP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment require any additional participants at present?
"As communicated on clinicaltrials.gov, this trial is not currently seeking participants. The research was initially announced on September 1st 2016 and the latest update took place on July 18th 2022. Although there are no more vacancies for enrolment at present, 740 other medical trials are actively recruiting volunteers."
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