Lumbar PunctureNCT02918149
Ultrasound Assisted Lumbar Puncture in the Neonate
A study testing Palpation Landmark Technique and Ultrasound-Assisted Technique LP in people with Lumbar Puncture, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- Palpation Landmark Technique and Ultrasound-Assisted Technique LP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates and infants aged ≤6 months
- Clinical indication for a lumbar puncture (LP), as determined by the clinical team
- Availability of study personnel to perform bedside ultrasound
Who cannot join
- Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
- Presence of skin and soft tissue infection at insertion site
- Recent failed LP traumatic LP attempts within the preceding 48 hours
- Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
- Clinically unstable patient, as determined by the clinical team
- Eligible patients on the resident care team
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of Ultrasound-Assisted Versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population
Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.
Read the detailed description
Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.
Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.
This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.
Primary Objective:
-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.
Secondary Objectives:
- To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts.
- To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.
- Conditions
- Lumbar Puncture
- Being tested
- Palpation Landmark Technique, Ultrasound-Assisted Technique LP
- Keywords
- Ultrasonography, Infant, Newborn, Lumbar puncture, Spinal puncture, Cerebrospinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palpation Landmark TechniqueOther
Also called Non-Ultrasound Assisted LP
Clinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by "blind" stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.
Ultrasound-Assisted Technique LPDevice
Also called Phillips CX50
Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a "safe zone". The study team member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.
| Study group | Role | What they receive |
|---|---|---|
| Palpation Landmark Technique LP | Other | Traditional landmark palpation technique will be used to perform LP Receives: Other: Palpation Landmark Technique |
| Ultrasound-Assisted Technique LP | Experimental | Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP Receives: Device: Ultrasound-Assisted Technique LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Successful First Attempt LPs
The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.
Measured: Up to 30 minutes
Secondary outcomes (2)
Proportion of Overall Success of LPs Within 2 Attempts
The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group. Providers will have 2 attempts to complete the LP. If CSF cannot be obtained within 2 attempts, any subsequent attempt will be at the discretion of the attending neonatologist and will be performed outside this study by the care team.
Measured: Up to 30 minutes
Difference in Length of Antibiotic Exposure
To determine whether bedside-ultrasound assisted LPs are associated with a decrease in the length of antibiotic exposure in patients undergoing LPs. If LP is unsuccessful, the mean length of antibiotic exposure as compared to patients with successful LPs will be compared.
Measured: Length of Hospitalization (approximately 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion1 Feb 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Stoller, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918149
- Sponsor's protocol ID
- 16-012757
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2016
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ekhaguere OA, Kesman R, Reiter J, Fraga MV, Stoller JZ. A Randomized Controlled Trial of Ultrasound-Assisted versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population. J Pediatr. 2026 Aug;295:115139. doi: 10.1016/j.jpeds.2026.115139. Epub 2026 May 6.
PubMed 42103066
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ultrasound-Assisted Versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population
- ClinicalTrials.gov ID
- NCT02918149
- Acronym / sponsor ID
- 16-012757
- Conditions
- Lumbar Puncture
- Keywords
- Ultrasonography, Infant, Newborn, Lumbar puncture, Spinal puncture, Cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.
Detailed description
Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.
Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.
This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.
Primary Objective:
-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.
Secondary Objectives:
- To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts.
- To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation Landmark Technique LP | Other | Other: Palpation Landmark TechniqueTraditional landmark palpation technique will be used to perform LP |
| Ultrasound-Assisted Technique LP | Experimental | Device: Ultrasound-Assisted Technique LPBedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates and infants aged ≤6 months
- Clinical indication for a lumbar puncture (LP), as determined by the clinical team
- Availability of study personnel to perform bedside ultrasound
Key exclusion criteria (6 listed)
- Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
- Presence of skin and soft tissue infection at insertion site
- Recent failed LP traumatic LP attempts within the preceding 48 hours
- Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
- Clinically unstable patient, as determined by the clinical team
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 |
|---|---|---|
| Palpation Landmark TechniqueAlso: Non-Ultrasound Assisted LPClinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by "blind" stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid. | Other | Palpation Landmark Technique LP |
| Ultrasound-Assisted Technique LPAlso: Phillips CX50Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a "safe zone". The study team member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid. | Device | Ultrasound-Assisted Technique LP |
Primary outcome
Proportion of Successful First Attempt LPs
Time frame: Up to 30 minutes
The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.
2 secondary outcomes
Proportion of Overall Success of LPs Within 2 Attempts
Time frame: Up to 30 minutes
Difference in Length of Antibiotic Exposure
Time frame: Length of Hospitalization (approximately 1 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42103066Ekhaguere OA, Kesman R, Reiter J, Fraga MV, Stoller JZ. A Randomized Controlled Trial of Ultrasound-Assisted versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population. J Pediatr. 2026 Aug;295:115139. doi: 10.1016/j.jpeds.2026.115139. Epub 2026 May 6.
- Individual participant dataSharing planned: No
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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.
Jason Stoller, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palpation Landmark Technique and Ultrasound-Assisted Technique LP in people with Lumbar Puncture, run by Children's Hospital of Philadelphia 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Successful First Attempt LPs (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918149, which also lists 1 linked publication.
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 13 Jul 2026.