Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01606150 · ClinicalTrials.gov registry record · NA
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
A NA study, sponsored by Georgetown University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT01606150: Clinical Trial NA study, sponsored by Georgetown University.
NCT01606150 is a NA study that was terminated before completion, run by Georgetown University. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606150, a NA study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's vertebrae. In the past, doctors did not know if newborns could feel the pain from a procedure like this in the same way that adults do. Investigators now know that the newborns do experience pain during this procedure, but we do not know the best way to control this pain. Investigators also think that when the newborns have pain, they move during the test. The movement can increase the chance of having blood mix with this normally clear fluid leading to limitations in our clinical application of these results. This study will compare the injected and topical forms of Lidocaine to see which gives us better pain control and more clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the rate of clinically useful results and pain scores. The investigators hypothesize that both forms of Lidocaine will be 25% superior to our historical control cohort in the rate of clinically useful results.
Primary Outcome
Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000
Interventions
- DRUG topical lidocaine
- DRUG 1% lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-07 |
| Phase | NA |
Why NCT01606150 stopped before completion
NCT01606150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which topical lidocaine is the first listed.
NCT01606150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01606150 about?
NCT01606150 is a clinical study titled "Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain". The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's vertebrae. In the past, d...
What is the current status of trial NCT01606150?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2012-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01606150?
The interventions under investigation include: topical lidocaine (DRUG), 1% lidocaine (DRUG).
Who is sponsoring clinical trial NCT01606150?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01606150's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia