Trial Outcomes & Findings for Ultrasound Assisted Lumbar Puncture in the Neonate (NCT NCT02918149)
NCT ID: NCT02918149
Last Updated: 2026-07-13
Results Overview
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.
COMPLETED
NA
91 participants
Up to 30 minutes
2026-07-13
Participant Flow
91 subjects were randomized and completed 95 LPs. Two infants were randomized to one traditional LP and one ultrasound LP; two infants were randomized to traditional LP twice.
Unit of analysis: Lumbar Puncture Procedures
Participant milestones
| Measure |
Palpation Landmark Technique LP
Traditional landmark palpation technique will be used to perform LP
Palpation Landmark Technique: 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.
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Ultrasound-Assisted Technique LP
Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP
Ultrasound-Assisted Technique LP: 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.
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|---|---|---|
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Overall Study
STARTED
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46 49
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45 46
|
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Overall Study
COMPLETED
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46 49
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45 46
|
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was collected at the time of each individual Lumbar Puncture Procedure.
Baseline characteristics by cohort
| Measure |
Traditional
n=49 Lumbar Puncture Procedures
Subjects who underwent an LP using a traditional technique
|
Ultrasound
n=46 Lumbar Puncture Procedures
Subjects who underwent an LP using an ultrasound-assisted technique
|
Total
n=95 Lumbar Puncture Procedures
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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22 Days
n=49 Lumbar Puncture Procedures • Age was collected at the time of each individual Lumbar Puncture Procedure.
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14 Days
n=46 Lumbar Puncture Procedures • Age was collected at the time of each individual Lumbar Puncture Procedure.
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15 Days
n=95 Lumbar Puncture Procedures • Age was collected at the time of each individual Lumbar Puncture Procedure.
|
|
Sex: Female, Male
Female
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20 Participants
n=47 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
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20 Participants
n=46 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
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40 Participants
n=91 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
|
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Sex: Female, Male
Male
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27 Participants
n=47 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
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26 Participants
n=46 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
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53 Participants
n=91 Participants • Sex was analyzed at the participant level. Two infants contributed to both arms; therefore, arm-level counts include these infants in both groups, while the Total column reflects 91 unique infants.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Two infants were randomized to one Traditional LP and one Ultrasound LP; two infants were randomized to Traditional LP twice. Number of attempts missing for one procedure.
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.
Outcome measures
| Measure |
Traditional
n=48 LP procedures
Subjects who underwent an LP using a traditional technique
|
Ultrasound
n=46 LP procedures
Subjects who underwent an LP using an ultrasound-assisted technique
|
|---|---|---|
|
Proportion of Successful First Attempt LPs
|
24 Successful procedure
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23 Successful procedure
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SECONDARY outcome
Timeframe: Up to 30 minutesPopulation: Two infants were randomized to one Traditional LP and one Ultrasound LP; two infants were randomized to Traditional LP twice.
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.
Outcome measures
| Measure |
Traditional
n=49 LP procedures
Subjects who underwent an LP using a traditional technique
|
Ultrasound
n=46 LP procedures
Subjects who underwent an LP using an ultrasound-assisted technique
|
|---|---|---|
|
Proportion of Overall Success of LPs Within 2 Attempts
|
43 Successful procedure
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38 Successful procedure
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SECONDARY outcome
Timeframe: Length of Hospitalization (approximately 1 month)Population: Two infants were randomized to one Traditional LP and one Ultrasound LP; two infants were randomized to Traditional LP twice.
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.
Outcome measures
| Measure |
Traditional
n=49 LP procedures
Subjects who underwent an LP using a traditional technique
|
Ultrasound
n=46 LP procedures
Subjects who underwent an LP using an ultrasound-assisted technique
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|---|---|---|
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Difference in Length of Antibiotic Exposure
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8 Days
Interval 3.0 to 11.0
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8 Days
Interval 3.0 to 11.3
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Adverse Events
Traditional
Ultrasound
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place