Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-29 @ 12:31 AM
Study NCT ID:
NCT05001334
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2021-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-20', 'releaseDate': '2023-09-11'}], 'estimatedResultsFirstSubmitDate': '2023-09-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological weight loss evaluation', 'timeFrame': '1 week', 'description': 'Physiological weight loss of term newborns whose mothers are trained about and perform kangaroo care, is theorised to be less than those who receive standard newborn care information. Periodical weight measurements will be recorded. To evaluate feeding efficiency, number of feedings and kangaroo care periods, changed diaper numbers will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['term newborn', 'weight loss', 'kangaroo care'], 'conditions': ['Infant, Newborn', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.', 'detailedDescription': 'The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.\n\nMothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.\n\nBreastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.\n\nA cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term babies born between 37-42 weeks of gestation\n* Newborns born vaginally\n* Newborns with developed sucking and swallowing reflexes\n\nExclusion Criteria:\n\n* Newborns born with C-section\n* Newborns in need of NICU care\n* Preterm newborns (born \\<37 weeks of gestation)\n* Newborns in need of oxygen\n* Genetic or metabolic disease (of the baby) limiting breastfeeding\n* HIV (+) mother\n* Mother having a chronic disease that will affect breastfeeding\n* Mother using drugs that pass into the breastmilk and affect the baby\n* Presence of a medical problem that will prevent the mother and baby from staying together'}, 'identificationModule': {'nctId': 'NCT05001334', 'briefTitle': 'Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Evaluating the Efficiency of Kangaroo Care on Physiological Weight Loss in Term Newborns by Means of Number of Feedings, Number of Diapers and Periodic Weight Measurements', 'orgStudyIdInfo': {'id': 'Kanguru'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kangaroo care', 'description': 'The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.', 'interventionNames': ['Behavioral: Kangaroo care training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The mothers of the control group who accept to participate in the research are NOT given any extra training other than routine breastfeeding and care of a newborn.'}], 'interventions': [{'name': 'Kangaroo care training', 'type': 'BEHAVIORAL', 'description': 'During perinatal period, mothers are given extra training (other than routine newborn care) about kangaroo care. Baby-mother diad is called for weight check-ups.', 'armGroupLabels': ['Kangaroo care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nuray Dilek', 'role': 'CONTACT', 'email': 'nevnuraydilek35@gmail.com', 'phone': '+905533919281'}, {'name': 'Nevin Hotun Sahin, Prof', 'role': 'CONTACT', 'email': 'nevinsah@istanbul.edu.tr', 'phone': '+905337294337'}], 'facility': 'Istanbul University-Cerrahpasa Florence Nightingale School of Nursing', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nuray Dilek', 'role': 'CONTACT', 'email': 'nevnuraydilek35@gmail.com', 'phone': '+905533919281'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If required participant information can be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse, MSc', 'investigatorFullName': 'Nuray Dilek', 'investigatorAffiliation': 'Istanbul University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-11', 'type': 'RELEASE'}, {'date': '2024-03-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nuray Dilek, Nurse, MSc, Istanbul University'}}}}