Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT06595368
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet', 'timeFrame': "Daily measurement from first day of neonate's admission to day 5 of admission", 'description': 'Total serum bilirubin level monitoring sheet: it includes 2 tests of total serum bilirubin level \\& indirect serum bilirubin tests. The daily measurement will be done, its primary purpose is to evaluate the effect of Vimala massage and hydrotherapy on newborns with Jaundice undergoing phototherapy. Bilirubin will be measured using microassay.'}, {'measure': "Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet", 'timeFrame': "Daily measurement from first day of neonate's admission to day 5 of admission", 'description': "Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight"}, {'measure': "Change from baseline of neonate's number of diaper exchange to monitor the frequency of defection and amount of stool on Bilirubin excretion monitoring sheet", 'timeFrame': "Daily measurement from first day of neonate's admission to day 5 of admission", 'description': "Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool"}, {'measure': "Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet", 'timeFrame': "Daily measurement from first day of neonate's admission to day 5 of admission", 'description': "Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount"}], 'secondaryOutcomes': [{'measure': 'Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool', 'timeFrame': 'through 5 days from admission', 'description': 'Clinical efficacy monitoring tool was developed by researchers after a review of relevant literature to assess the effectiveness of Vimala massage and Hydrotherapy in accelerating the regression time of jaundice.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Jaundice']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.', 'detailedDescription': "The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow:\n\nControl Group: Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.\n\nStudy Group (I): Consisted of 30 neonates who will receive Vimala massage. The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.\n\nStudy Group (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '37 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nfull-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal\n\nExclusion Criteria:\n\n* major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby)."}, 'identificationModule': {'nctId': 'NCT06595368', 'briefTitle': 'Comparing the Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia', 'orgStudyIdInfo': {'id': 'KafrelsheikhU3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.'}, {'type': 'EXPERIMENTAL', 'label': 'Study group I (Vimala group)', 'description': 'Consisted of 30 neonates who will receive Vimala massage.', 'interventionNames': ['Procedure: Vimala massage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study group II (Hydrotherapy)', 'description': 'Consisted of 30 neonates who will receive hydrotherapy.', 'interventionNames': ['Procedure: Hydrotherapy']}], 'interventions': [{'name': 'Vimala massage', 'type': 'PROCEDURE', 'description': 'The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.', 'armGroupLabels': ['Study group I (Vimala group)']}, {'name': 'Hydrotherapy', 'type': 'PROCEDURE', 'description': 'Hydrotherapy will be applied two times per day before feeding, each lasting 5-10 min.', 'armGroupLabels': ['Study group II (Hydrotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of pediatric nursing', 'investigatorFullName': 'Eman Wardany Abdelaal Mohamed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}