Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-20 @ 11:37 PM
Study NCT ID:
NCT04267302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baby Item Learning and Development Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive skill as assessed via eye tracking', 'timeFrame': '8 months', 'description': 'Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.'}, {'measure': 'Parental Engagement', 'timeFrame': '8 months', 'description': 'Mother and infant will engage in a 15-minute unstructured free playtime. This engagement will be videotaped and assessed by the Investigator. Parental engagement is reported as the percentage of parental sensitivity and synchrony scored on a 0-100% scale with the higher score indicating increased sensitivity and synchrony.'}, {'measure': 'Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure', 'timeFrame': '8 months', 'description': 'Infant emotions and social engagement is reported as the time noted when the infant was crying during the 6 minute Face to Face/Still Face Procedure.'}, {'measure': 'Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure', 'timeFrame': '8 months', 'description': 'Infant emotions and social engagement is reported as the time noted when the infant was smiling during the 6 minute Face to Face/Still Face Procedure.'}, {'measure': 'Oxytocin levels', 'timeFrame': '8 months', 'description': 'Mother and infant oxytocin levels will be measured via saliva sample.'}, {'measure': 'Percentage of infant and adult vocalizations time', 'timeFrame': 'Up to 8 hours', 'description': 'Assessed via 2-8 hours audio recordings on LENA.'}, {'measure': 'Percentage of infant and adult turn taking', 'timeFrame': 'Up to 8 hours', 'description': 'Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.'}, {'measure': 'Percentage of Infant crying time', 'timeFrame': 'Up to 8 hours', 'description': 'Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant Development']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to experimentally test whether baby items can promote healthy infant development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers and their infants must be healthy with no known birth complications\n* Infants must be born full term (at least 37 weeks gestation)\n* Mother must speak English\n* Mothers must be at least 28 weeks along in their pregnancy. Mothers with newborns who are less than 2 weeks will be included.\n\nExclusion Criteria:\n\n* Participants who does not meet all the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04267302', 'briefTitle': 'Baby Item Learning and Development Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Baby Item Learning and Development Study', 'orgStudyIdInfo': {'id': '20190970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Baby Bouncer Group', 'description': "Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.", 'interventionNames': ['Other: Baby Bouncer']}, {'type': 'OTHER', 'label': 'Baby Bouncer Group with Infant T-Shirt with LENA', 'description': 'A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.', 'interventionNames': ['Other: Baby Bouncer', 'Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders']}, {'type': 'OTHER', 'label': 'Baby Carrier Group', 'description': "Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth.", 'interventionNames': ['Other: Baby Carrier']}, {'type': 'OTHER', 'label': 'Baby Carrier Group with Infant T-Shirt with LENA', 'description': 'A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.', 'interventionNames': ['Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders', 'Other: Baby Carrier']}], 'interventions': [{'name': 'Baby Bouncer', 'type': 'OTHER', 'description': 'Fischer Price baby bouncer.', 'armGroupLabels': ['Baby Bouncer Group', 'Baby Bouncer Group with Infant T-Shirt with LENA']}, {'name': 'Infant t-shirts with Language Environment Analysis (LENA) audio recorders', 'type': 'OTHER', 'description': 'Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.', 'armGroupLabels': ['Baby Bouncer Group with Infant T-Shirt with LENA', 'Baby Carrier Group with Infant T-Shirt with LENA']}, {'name': 'Baby Carrier', 'type': 'OTHER', 'description': 'Ergobaby Baby carrier.', 'armGroupLabels': ['Baby Carrier Group', 'Baby Carrier Group with Infant T-Shirt with LENA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Elizabeth Simpson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Simpson', 'investigatorAffiliation': 'University of Miami'}}}}