Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05282394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2021-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the newborn massage intervention', 'timeFrame': 'Through study completion, up to one year', 'description': 'Acceptability of the intervention will be defined by the 1-sided 95% confidence interval for the proportion of the intervention group performing massage at least once to include 80% and for the 1-sided 95% confidence interval for at the proportion performing massage as directed to include 70%.'}, {'measure': 'Feasibility of recruitment', 'timeFrame': 'Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.', 'description': 'Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.'}], 'secondaryOutcomes': [{'measure': 'Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge', 'timeFrame': 'Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year', 'description': "delta-TcSB, which is calculated by subtracting infant's transcutaneous bilirubin level from their phototherapy treatment threshold at that hour of age (in mg/dL)"}, {'measure': 'Number of stools in prior 24 hours (at hospital discharge)', 'timeFrame': 'Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year'}, {'measure': 'Timing of first transitional (non-meconium) stool passage', 'timeFrame': 'Ascertained at 1-2 week survey'}, {'measure': 'Parental satisfaction with newborn massage', 'timeFrame': '7-14 day survey', 'description': 'Parental satisfaction with newborn massage assessed by survey'}, {'measure': 'Proportion of participants who read with baby in the last 24 hours', 'timeFrame': '1-2 week survey', 'description': 'Proportion of participants who read with baby in the last 24 hours assessed by survey'}, {'measure': 'Proportion of participants who read with baby in the last week', 'timeFrame': '1-2 week survey', 'description': 'Proportion of participants who read with baby in the last week assessed by survey'}, {'measure': 'Breastfeeding at 1 week of age', 'timeFrame': '1-2 week survey', 'description': 'Infant received any human milk in the prior 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newborn massage'], 'conditions': ['Newborn Jaundice']}, 'descriptionModule': {'briefSummary': 'The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '0 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center\n* Less than 48 hours of age at enrollment\n\nExclusion Criteria:\n\n* Infant has already received phototherapy\n* Mother/birthing person is incarcerated\n* Infant unexpected to discharge into parental care\n* Parental inability to speak or read in English\n* Infant without parent rooming-in with them in the hospital'}, 'identificationModule': {'nctId': 'NCT05282394', 'briefTitle': 'Newborn Abdominal Massage to Prevent Hyperbilirubinemia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1817729'}, 'secondaryIdInfos': [{'id': 'K12HD051958', 'link': 'https://reporter.nih.gov/quickSearch/K12HD051958', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Massage Intervention', 'description': 'Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life', 'interventionNames': ['Procedure: Abdominal massage']}, {'type': 'OTHER', 'label': 'Attention Control Intervention', 'description': 'Families will be provided with information about reading with baby.', 'interventionNames': ['Other: Reading']}], 'interventions': [{'name': 'Abdominal massage', 'type': 'PROCEDURE', 'description': 'abdominal massage', 'armGroupLabels': ['Massage Intervention']}, {'name': 'Reading', 'type': 'OTHER', 'description': 'guidance given to parents about reading with baby', 'armGroupLabels': ['Attention Control Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Laura Kair, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}