Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-01 @ 7:24 AM
Study NCT ID:
NCT06129266
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2023-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Care With Breast Milk in Preterm Newborns Fed by Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2023-11-04', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study', 'timeFrame': 'from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.', 'description': 'Oral care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breastmilk', 'oral care', 'newborn'], 'conditions': ['Breastmilk', 'Oral Care']}, 'descriptionModule': {'briefSummary': 'It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube', 'detailedDescription': 'Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '33 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -Staying in the neonatal intensive care unit\n* Being fed by gavage\n* Babies with no oral intake (nonperoral-NPO)\n* Babies fed with breast milk and/or formula\n\nExclusion Criteria:\n\n* Babies who are exclusively breastfed\n* Cleft palate/lip\n* Major congenital anomaly\n* Intubated babies'}, 'identificationModule': {'nctId': 'NCT06129266', 'briefTitle': 'Oral Care With Breast Milk in Preterm Newborns Fed by Tube', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '13/38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'İntervention (Oral care with breastmilk) group', 'description': 'Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.', 'interventionNames': ['Other: oral care with breastmilk']}, {'type': 'NO_INTERVENTION', 'label': 'Routine maintenance group', 'description': 'No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice.'}], 'interventions': [{'name': 'oral care with breastmilk', 'type': 'OTHER', 'otherNames': ['routine maintenance'], 'description': 'No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice.', 'armGroupLabels': ['İntervention (Oral care with breastmilk) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ayse Cuvadar', 'investigatorAffiliation': 'Karabuk University'}}}}