Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-05 @ 8:49 PM
Study NCT ID:
NCT02133066
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2014-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
Sponsor:
Organization:
Raw JSON
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The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'US-Assisted Site Marking for LP', 'description': 'Mindray M7 Ultrasound marking\n\nBedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.\n\nMindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap'}, {'id': 'OG001', 'title': 'Routine Lumbar Puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '70'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '39'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group', 'unitOfMeasure': 'percent success', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'US-Assisted Site Marking for LP', 'description': 'Mindray M7 Ultrasound marking\n\nBedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.\n\nMindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap'}, {'id': 'OG001', 'title': 'Routine Lumbar Puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '82'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group', 'unitOfMeasure': 'percentage success', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'US-Assisted Site Marking for LP', 'description': 'Mindray M7 Ultrasound marking\n\nBedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.\n\nMindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap'}, {'id': 'OG001', 'title': 'Routine Lumbar Puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '61'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an expected average of 2 days', 'description': 'If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'US-Assisted Site Marking for LP', 'description': 'Mindray M7 Ultrasound marking\n\nBedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.\n\nMindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap'}, {'id': 'OG001', 'title': 'Routine Lumbar Puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '30'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed until discontinuation of antibiotics, an expected average of 2 days', 'description': 'If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'US-Assisted Site Marking for LP', 'description': 'Mindray M7 Ultrasound marking\n\nBedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.\n\nMindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap'}, {'id': 'FG001', 'title': 'Routine Lumbar Puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; 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The patients will simply have a "standard-of-care" spinal tap performed by the clinician\n\nRoutine lumbar puncture: Lumbar puncture will be performed per routine standard of care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '34'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '45'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '179'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2014-05-02', 'resultsFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-01', 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group', 'timeFrame': '30 minutes', 'description': 'First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group'}], 'secondaryOutcomes': [{'measure': 'Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group', 'timeFrame': '30 minutes', 'description': 'Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group'}, {'measure': 'Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an expected average of 2 days', 'description': 'If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.'}, {'measure': 'Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients', 'timeFrame': 'Participants will be followed until discontinuation of antibiotics, an expected average of 2 days', 'description': 'If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Lumbar Puncture', 'Spinal Tap', 'Pediatric', 'Infant', 'Bedside Ultrasonography'], 'conditions': ['Traumatic Lumbar Puncture']}, 'referencesModule': {'references': [{'pmid': '20403933', 'type': 'BACKGROUND', 'citation': 'Abo A, Chen L, Johnston P, Santucci K. Positioning for lumbar puncture in children evaluated by bedside ultrasound. Pediatrics. 2010 May;125(5):e1149-53. doi: 10.1542/peds.2009-0646. Epub 2010 Apr 19.'}, {'pmid': '16510670', 'type': 'BACKGROUND', 'citation': 'Baxter AL, Fisher RG, Burke BL, Goldblatt SS, Isaacman DJ, Lawson ML. Local anesthetic and stylet styles: factors associated with resident lumbar puncture success. Pediatrics. 2006 Mar;117(3):876-81. doi: 10.1542/peds.2005-0519.'}, {'pmid': '21444601', 'type': 'BACKGROUND', 'citation': 'Bruccoleri RE, Chen L. Needle-entry angle for lumbar puncture in children as determined by using ultrasonography. Pediatrics. 2011 Apr;127(4):e921-6. doi: 10.1542/peds.2010-2511. Epub 2011 Mar 28.'}, {'pmid': '11692234', 'type': 'BACKGROUND', 'citation': 'Coley BD, Murakami JW, Koch BL, Shiels WE 2nd, Bates G, Hogan M. Diagnostic and interventional ultrasound of the pediatric spine. Pediatr Radiol. 2001 Nov;31(11):775-85. doi: 10.1007/s002470100535.'}, {'pmid': '18810417', 'type': 'BACKGROUND', 'citation': 'Dietrich AM, Coley BD. Bedside pediatric emergency evaluation through ultrasonography. Pediatr Radiol. 2008 Nov;38 Suppl 4:S679-84. doi: 10.1007/s00247-008-0890-1. Epub 2008 Sep 23.'}, {'pmid': '17349903', 'type': 'BACKGROUND', 'citation': 'Ferre RM, Sweeney TW. Emergency physicians can easily obtain ultrasound images of anatomical landmarks relevant to lumbar puncture. Am J Emerg Med. 2007 Mar;25(3):291-6. doi: 10.1016/j.ajem.2006.08.013.'}, {'pmid': '11892638', 'type': 'BACKGROUND', 'citation': 'Furness G, Reilly MP, Kuchi S. An evaluation of ultrasound imaging for identification of lumbar intervertebral level. Anaesthesia. 2002 Mar;57(3):277-80. doi: 10.1046/j.1365-2044.2002.2403_4.x.'}, {'pmid': '14984904', 'type': 'BACKGROUND', 'citation': 'Lam WW, Ai V, Wong V, Lui WM, Chan FL, Leong L. Ultrasound measurement of lumbosacral spine in children. Pediatr Neurol. 2004 Feb;30(2):115-21. doi: 10.1016/j.pediatrneurol.2003.07.002.'}, {'pmid': '17321005', 'type': 'BACKGROUND', 'citation': 'Nigrovic LE, Kuppermann N, Neuman MI. Risk factors for traumatic or unsuccessful lumbar punctures in children. Ann Emerg Med. 2007 Jun;49(6):762-71. doi: 10.1016/j.annemergmed.2006.10.018. Epub 2007 Feb 23.'}, {'pmid': '21492866', 'type': 'BACKGROUND', 'citation': 'Nigrovic LE, Shah SS, Neuman MI. Correction of cerebrospinal fluid protein for the presence of red blood cells in children with a traumatic lumbar puncture. J Pediatr. 2011 Jul;159(1):158-9. doi: 10.1016/j.jpeds.2011.02.038. Epub 2011 Apr 14.'}, {'pmid': '17901137', 'type': 'BACKGROUND', 'citation': "Nomura JT, Leech SJ, Shenbagamurthi S, Sierzenski PR, O'Connor RE, Bollinger M, Humphrey M, Gukhool JA. A randomized controlled trial of ultrasound-assisted lumbar puncture. J Ultrasound Med. 2007 Oct;26(10):1341-8. doi: 10.7863/jum.2007.26.10.1341."}, {'pmid': '22684159', 'type': 'BACKGROUND', 'citation': 'Oncel S, Gunlemez A, Anik Y, Alvur M. Positioning of infants in the neonatal intensive care unit for lumbar puncture as determined by bedside ultrasonography. Arch Dis Child Fetal Neonatal Ed. 2013 Mar;98(2):F133-5. doi: 10.1136/archdischild-2011-301475. Epub 2012 Jun 9.'}, {'pmid': '20577138', 'type': 'BACKGROUND', 'citation': 'Pappano D. "Traumatic tap" proportion in pediatric lumbar puncture. Pediatr Emerg Care. 2010 Jul;26(7):487-9. doi: 10.1097/PEC.0b013e3181e5bedd.'}, {'pmid': '15707816', 'type': 'BACKGROUND', 'citation': 'Peterson MA, Abele J. Bedside ultrasound for difficult lumbar puncture. J Emerg Med. 2005 Feb;28(2):197-200. doi: 10.1016/j.jemermed.2004.09.008.'}, {'pmid': '8424014', 'type': 'BACKGROUND', 'citation': 'Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.'}, {'pmid': '520695', 'type': 'BACKGROUND', 'citation': 'Schreiner RL, Kleiman MB. Incidence and effect of traumatic lumbar puncture in the neonate. Dev Med Child Neurol. 1979 Aug;21(4):483-7. doi: 10.1111/j.1469-8749.1979.tb01652.x.'}, {'pmid': '23624433', 'type': 'BACKGROUND', 'citation': 'Srinivasan L, Shah SS, Abbasi S, Padula MA, Harris MC. Traumatic lumbar punctures in infants hospitalized in the neonatal intensive care unit. Pediatr Infect Dis J. 2013 Oct;32(10):1150-2. doi: 10.1097/INF.0b013e31829862b7.'}]}, 'descriptionModule': {'briefSummary': 'The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.', 'detailedDescription': "The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of \\~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than or equal to six months of age\n* Plan for diagnostic or therapeutic lumbar puncture as per front line clinician\n* Availability of a study sonographer to perform bedside ultrasound\n\nExclusion Criteria:\n\n* Known spinal cord abnormality (e.g., tethered cord, spina bifida)'}, 'identificationModule': {'nctId': 'NCT02133066', 'briefTitle': 'The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '13-010667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'US-Assisted site marking for Lumbar Punctures (LP)', 'description': 'Mindray M7 Ultrasound marking', 'interventionNames': ['Procedure: Bedside Ultrasound-Assisted Site Marking', 'Device: Mindray M7 Ultrasound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine lumbar puncture', 'description': 'These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician', 'interventionNames': ['Procedure: Routine lumbar puncture']}], 'interventions': [{'name': 'Bedside Ultrasound-Assisted Site Marking', 'type': 'PROCEDURE', 'otherNames': ['Mindray M7 Ultrasound'], 'description': 'Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.', 'armGroupLabels': ['US-Assisted site marking for Lumbar Punctures (LP)']}, {'name': 'Mindray M7 Ultrasound', 'type': 'DEVICE', 'otherNames': ['M7/M7T Diagnostic Ultrasound'], 'description': 'Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap', 'armGroupLabels': ['US-Assisted site marking for Lumbar Punctures (LP)']}, {'name': 'Routine lumbar puncture', 'type': 'PROCEDURE', 'description': 'Lumbar puncture will be performed per routine standard of care', 'armGroupLabels': ['Routine lumbar puncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia Emergency Department", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Aaron E Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHOP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}