Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT07231432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Aim 1 consists of focus groups and qualitative analysis. Aim 2 consists of pilot testing interventions. Aim 3 includes the interventional study model, which is described here. As a part of the Multiphase Optimization Strategy (MOST) design-based trial, Aim 3 consists of an optimization trial using full factorial design to test combinations of intervention components, known as experimental conditions, and identify key combinations to include in an optimized, multicomponent intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-12', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of community-based Kangaroo Care use', 'timeFrame': '6 weeks', 'description': 'Self-report of any Kangaroo Care at home after NICU discharge'}], 'secondaryOutcomes': [{'measure': 'Maternal Intention to perform Kangaroo Care', 'timeFrame': 'Baseline (day 0)', 'description': 'Self-report of intention to perform Kangaroo Care at home'}, {'measure': 'Maternal Self-Efficacy to perform Kangaroo Care', 'timeFrame': '6 weeks', 'description': 'Maternal Self-Efficacy Scale questionnaire'}, {'measure': 'Adherence to community-based Kangaroo Care', 'timeFrame': '6 weeks', 'description': 'Self-report of the last date Kangaroo Care was performed at home'}, {'measure': 'Frequency of community-based Kangaroo Care use', 'timeFrame': '6 weeks', 'description': 'Self-report of number of days Kangaroo Care was provided at home'}, {'measure': 'Acceptability of the intervention', 'timeFrame': '6 weeks', 'description': 'Client Satisfaction Questionnaire'}, {'measure': 'Appropriateness of the intervention', 'timeFrame': '6 weeks', 'description': 'Qualitative Exit Interview with a trained member of the research staff'}, {'measure': 'Material Costs of the intervention', 'timeFrame': '6 weeks', 'description': 'Cumulative cost of intervention delivery per participant'}, {'measure': 'Engagement with the intervention', 'timeFrame': '6 weeks', 'description': 'Self-reported engagement with intervention (# of instances)'}, {'measure': 'Feasibility of the intervention', 'timeFrame': '6 weeks', 'description': 'Feasibility of Intervention Measure questionnaire'}, {'measure': 'Usability of the intervention', 'timeFrame': '6 weeks', 'description': 'System Usability Scale questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth', 'Skin to Skin Contact', 'Low Birth Weight', 'Kangaroo Care']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop ways to help mothers of preterm or low birth weight infants do Kangaroo Care at home after discharge from the Neonatal Intensive Care Unit in rural India.', 'detailedDescription': 'This study aims to create and evaluate interventions to support the practice of Kangaroo Care among mothers of preterm or low birth weight infants in the community-seeing after discharge from the Neonatal Intensive Care Unity. Using a mixed methods and Multiphase Optimization Strategy (MOST) design-based trial, we aim to: Aim 1: Use community-engaged research and qualitative methods to refine up to four individual candidate interventions to overcome barriers to community-based Kangaroo Care, Aim 2: Pilot individual candidate interventions to assess implementation outcomes and define optimization criterion tailored for the community setting, Aim 3: Conduct a MOST design-based optimization trial to develop a community-informed, multicomponent intervention to promote community-based Kangaroo Care'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'AIM 1\n\nMothers\n\n* Mothers of former low birthweight (\\<2500 grams at birth) infants who were hospitalized in the Shree Krishna Hospital NICU\n* Performed Kangaroo Care during their infant\'s hospitalization\n* Live in a village that is "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital\n* At least 18 years old\n* Speak Gujarati\n\nHealthcare Providers- Physicians:\n\n* Physicians and nurses who work in either the Shree Krishna Hospital NICU or in community settings within a 50-kilometer radius who provide newborn care to at least 3 newborns each week\n* At least 18 years old\n* Speak Gujarati\n\nVillage Health Workers:\n\n* Village health workers who operate in one of the "adopted" villages within a 50-kilometer radius of Shree Krishna Hospital\n* We will aim to recruit one health worker from 10 of the 15 subregions of the district of Anand, based on geography\n* At least 18 years old\n* Speak Gujarati\n\nAIM 2\n\nMothers:\n\n* Mothers of an infant born with low birthweight (\\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g\n* Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge\n* Speaks Gujarati\n* At least 18 years old\n\nAIM 3\n\nMothers:\n\n* Mothers of an infant born with low birthweight (\\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g\n* Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge\n* Speaks Gujarati\n* At least 18 years old\n\nExclusion Criteria (applicable to all aims)\n\n* Persons unable to provide informed consent\n* Pregnant women may enroll in this study, though, we will not be intentionally recruiting pregnant women. (Refer to section 18 for more information on this)\n* Prisoners will not be included in the study'}, 'identificationModule': {'nctId': 'NCT07231432', 'briefTitle': 'Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Promoting Community-based Kangaroo Care Among Mothers of Low Birth Weight Infants in Rural India', 'orgStudyIdInfo': {'id': 'K23HD112602', 'link': 'https://reporter.nih.gov/quickSearch/K23HD112602', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23HD112602-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K23HD112602-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Interventions A + B + C', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Interventions A + B', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Interventions A + C', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Intervention A', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Interventions B + C', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Intervention B', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Base Intervention + Behavioral Intervention C', 'interventionNames': ['Behavioral: Behavioral Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Base Intervention + No Experimental Behavioral Interventions'}], 'interventions': [{'name': 'Behavioral Interventions', 'type': 'BEHAVIORAL', 'description': 'The interventions have not been determined yet. The intervention aspect of the study is not active at this time. This information will be updated at a later time to include more details.', 'armGroupLabels': ['Base Intervention + Behavioral Intervention A', 'Base Intervention + Behavioral Intervention B', 'Base Intervention + Behavioral Intervention C', 'Base Intervention + Behavioral Interventions A + B', 'Base Intervention + Behavioral Interventions A + B + C', 'Base Intervention + Behavioral Interventions A + C', 'Base Intervention + Behavioral Interventions B + C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Nisha Fahey, DO, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Chan Medical School'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'All scientific data that can be shared from this project will be made available as soon as possible, and no later than 12 months of the end of the funding period. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.', 'ipdSharing': 'YES', 'description': 'Sufficient data from this project will be preserved to validate and replicate research findings described in the Aims. The final dataset will include self-reported demographics, behavioral beliefs, acceptability, appropriateness, material costs, engagement, feasibility, usability, uptake, frequency, and adherence. Additional data sets will include coded qualitative data. We will share de-identified individual participant-level data.', 'accessCriteria': 'All dataset(s) that can be shared, along with related metadata, will be deposited in the Harvard Dataverse Repository (https://dataverse.harvard.edu/). This will ensure the research community has long-term access to the data. Dataverse provides a DOI for the dataset related to this project, providing permanent identification for the data and ensuring that it will always be found with the same DOI. Its software platform provides a preservation and archival infrastructure and allows researchers to share, keep control of, and get recognition for their data through an easy-to-access web browser interface.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Nisha Fahey', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}