Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-07 @ 6:08 AM
Study NCT ID:
NCT03370757
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2017-12-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debra.brandon@duke.edu', 'phone': '919-681-3813', 'title': 'Dr. Debra Brandon', 'organization': 'Duke University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During hospitalization, approximately four weeks.', 'eventGroups': [{'id': 'EG000', 'title': '3 Hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '6 Hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 6 hours during 3-hour bundled care.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Heart Rate by Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 3 hours during 3-hour bundled care.\n\n3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours.'}, {'id': 'OG001', 'title': '6-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 6 hours.\n\n6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'spread': '75.19', 'groupId': 'OG000'}, {'value': '185', 'spread': '73.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \\< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 3 hours.\n\n3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours with trans epidermal water loss measurements taken 3 times per week.'}, {'id': 'OG001', 'title': '6-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 6 hours.\n\n6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours with trans epidermal water loss measurements taken 4 times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.48', 'groupId': 'OG000', 'lowerLimit': '31.93', 'upperLimit': '45.03'}, {'value': '35.73', 'groupId': 'OG001', 'lowerLimit': '29.67', 'upperLimit': '41.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'TEWL was measured at the beginning of each bundled care event using the DermaLab® TEWL probe (Cortex Technology, Hadsund, Denmark). Transepidermal water loss is the process of water moving through the layers of the skin and evaporating.\n\nLinear mixed models (LMM) were used to examine group differences in TEWL. Outcomes in these models consisted of within-subject change over time in skin TEWL of the buttock. In the model, TEWL was regressed on diaper change group and the number of days since study initiation. TEWL estimates and confidence intervals are reported by group across all bundled care observations.', 'unitOfMeasure': 'g/m^2/h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 3 hours.\n\nSkin swabs were collected on the buttocks \\& chest from infants up to 3 times per week during their assigned diaper change interval from the time of initiation of the intervention until discharge. Stool samples were collected 1 time per week when available.'}, {'id': 'OG001', 'title': '6-hour Bundled Care', 'description': 'Infants in this group had their diaper changed every 6 hours.\n\nSkin swabs were collected on the buttocks \\& chest from infants up to 3 times per week during their assigned diaper change interval from the time of initiation of the intervention until discharge. Stool samples were collected 1 time per week when available.'}], 'classes': [{'title': 'Skin-Buttocks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Skin-Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.16', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'The Shannon Diversity index measures the alpha diversity of a bacterial sample. Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'A total of 273 skin swabs from the buttocks were analyzed from infants in the 3-hr bundled care group and 255 swabs from infants in the 6-hr bundled care group. A total of 266 skin swabs from the chest were analyzed from infants in the 3-hr bundled care group and 254 swabs from infants in the 6-hr bundled care group. A total of 65 stool samples were analyzed from infants in the 3-hr bundled care group and 66 samples from infants in the 6-hr bundled care group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3-hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.\n\n3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.'}, {'id': 'FG001', 'title': '6-hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 6 hours.\n\n6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment Period: 2/2018 - 7/2019 Location: Level IV NICU', 'preAssignmentDetails': '1 infant was consented but discharged home before being randomized because the infant never reached q3 hour feedings (discharged home on G-tube).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3-hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.\n\n3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.'}, {'id': 'BG001', 'title': '6-hour Bundled Care', 'description': 'Infants in this group will have their diaper changed every 6 hours.\n\n6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age at Birth', 'categories': [{'measurements': [{'value': '27.6', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-12', 'size': 243746, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-26T11:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Infants will be randomly assigned and stratified by birth weight (≤ 800 grams, \\>800 grams to 1150 grams, \\> 1150 grams) to either 3- or 6- hour bundled diaper care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2017-12-01', 'resultsFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-12', 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Heart Rate by Group', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \\< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.'}], 'secondaryOutcomes': [{'measure': 'Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'TEWL was measured at the beginning of each bundled care event using the DermaLab® TEWL probe (Cortex Technology, Hadsund, Denmark). Transepidermal water loss is the process of water moving through the layers of the skin and evaporating.\n\nLinear mixed models (LMM) were used to examine group differences in TEWL. Outcomes in these models consisted of within-subject change over time in skin TEWL of the buttock. In the model, TEWL was regressed on diaper change group and the number of days since study initiation. TEWL estimates and confidence intervals are reported by group across all bundled care observations.'}, {'measure': 'Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group', 'timeFrame': 'During hospitalization, approximately four weeks', 'description': 'The Shannon Diversity index measures the alpha diversity of a bacterial sample. Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '34896732', 'type': 'DERIVED', 'citation': "Brandon DH, Hatch D, Barnes A, Vance AJ, Harney J, Voigtman B, Younge N. Impact of diaper change frequency on preterm infants' vital sign stability and skin health: A RCT. Early Hum Dev. 2022 Jan;164:105510. doi: 10.1016/j.earlhumdev.2021.105510. Epub 2021 Nov 20."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.', 'detailedDescription': 'Preterm infants\' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. The variations in preterm infants\' outcomes have led to the supposition that the neonatal intensive care unit (NICU) environment may negatively impact the health and development of these infants and significant research has been devoted to examination of light, noise, and caregiving interventions. Consequently, many NICUs have implemented neuroprotective strategies to reduce over simulation, promote sleep and facilitate brain development in high-risk infants including the grouping of care activities around a single caregiving event described as "clustering" or "bundling care". Yet, the number and type of caregiving activities that are included in bundled care and the timeframe between bundled care events has not been systematically studied. The inclusion and exclusion of certain care activities in any individual care event is often dictated by the infant\'s treatment plan or needs, but some activities like diapering may be optional. Understanding the impact of when to include optional, yet stress provoking interventions, will allow us to minimize overall environmental stress in hospitalized very low birthweight (VLBW) infants. Therefore, given the lack of data around bundled care, the investigators aim to explore through a randomized controlled design the impact of bundling diaper care activities on overall health of VLBW preterm infants. The investigators will include a focus on skin health because it is important to understand the benefits of decreased infant stress and any potential skin health trade-offs associated with longer versus shorter time between diapering care. Findings from this study will allow us to better understand the relationship between neonatal skin health while providing developmentally appropriate bundled care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be participating in the Intensive Care Nursery standard 3-hour bundled care\n2. Must wear a breathable diaper\n3. Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth.\n4. Infants are expected to remain hospitalized for at least 4 weeks\n\nExclusion Criteria:\n\n1. Neonatal Abstinence Syndrome\n2. Humidified incubator\n3. Diaper rash\n4. Pre-existing or genetic skin conditions\n5. Use of barrier creams\n6. Severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.'}, 'identificationModule': {'nctId': 'NCT03370757', 'briefTitle': 'Very Low Birth Weight Preterm Infant Bundled Care in the NICU', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro00086595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3-hour bundled care', 'description': 'Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.', 'interventionNames': ['Other: 3-hour bundled care']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6-hour bundled care', 'description': 'Infants in this group will have their diaper changed every 6 hours.', 'interventionNames': ['Other: 6-hour bundled care']}], 'interventions': [{'name': '3-hour bundled care', 'type': 'OTHER', 'description': 'Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.', 'armGroupLabels': ['3-hour bundled care']}, {'name': '6-hour bundled care', 'type': 'OTHER', 'description': 'Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.', 'armGroupLabels': ['6-hour bundled care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Debra Brandon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kimberly-Clark Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}