Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-05 @ 1:53 PM
Study NCT ID:
NCT03337893
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BP', 'timeFrame': 'Baseline for age 5', 'description': 'Blood Pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Feeding', 'Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gökçay G, Garipağaoğlu M. Çocukluk ve Ergenlik Döneminde Beslenme. İstanbul: Saga Yayınları, 2002: 24-63.'}, {'type': 'BACKGROUND', 'citation': 'Gökçay G, Garibağaoğlu M. Sağlıklı Çocuğun Beslenmesi. İçinde: Neyzi O, Ertuğrul T: Pediatri. 1. Cilt. İstanbul: Nobel Tıp Kitabevi, 2002: 183-202.'}, {'type': 'BACKGROUND', 'citation': 'American Academy of Pediatrics. Nutrition and Immunitiy. Chapter 31. In: Pediatric Nutriton Handbook CD- ROM. 4 th ed. Elk Growe Village: Abbott Laboratories, 1998: 473-84.'}, {'type': 'BACKGROUND', 'citation': 'Lawrens RA, Lawrence RM. Host-resistance factors and immunologic significance of human milk. In: Lawrens RA, Lawrence RM (eds). Breastfeeding. St. Louis: Mosby, 1994: 159-95.'}, {'type': 'BACKGROUND', 'citation': 'T.C. Sağlık Bakanlığı, Hacettepe Üniversitesi Nüfus Etüdleri Enstitüsü. Türkiye Nüfus ve Sağlık Araştırması 2003. Ankara: Macro International Inc, 2003.'}, {'type': 'BACKGROUND', 'citation': 'Hacettepe Üniversitesi Nüfus Etütleri Enstitüsü (2014), "2013 Türkiye Nüfus ve Sağlık Araştırması". Hacettepe Üniversitesi Nüfus Etütleri Enstitüsü, T.C. Kalkınma Bakanlığı ve TÜBİTAK, Ankara, Türkiye'}, {'pmid': '20111658', 'type': 'BACKGROUND', 'citation': 'Stuebe A. The risks of not breastfeeding for mothers and infants. Rev Obstet Gynecol. 2009 Fall;2(4):222-31.'}, {'pmid': '18065591', 'type': 'BACKGROUND', 'citation': 'Kramer MS, Matush L, Vanilovich I, Platt RW, Bogdanovich N, Sevkovskaya Z, Dzikovich I, Shishko G, Collet JP, Martin RM, Davey Smith G, Gillman MW, Chalmers B, Hodnett E, Shapiro S; PROBIT Study Group. Effects of prolonged and exclusive breastfeeding on child height, weight, adiposity, and blood pressure at age 6.5 y: evidence from a large randomized trial. Am J Clin Nutr. 2007 Dec;86(6):1717-21. doi: 10.1093/ajcn/86.5.1717.'}, {'type': 'BACKGROUND', 'citation': 'Mazıcıoğlu MM.Büyüme gelişme izleminde kullanılan antropometrik ölçüm yöntemleri: Büyüme takibinin metodolojisi.Türkiye Aile Hekimliği Dergisi 2011;15(3):101-108.'}, {'pmid': '17625394', 'type': 'BACKGROUND', 'citation': 'Altunkan S, Ilman N, Kayaturk N, Altunkan E. Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults. Blood Press Monit. 2007 Aug;12(4):219-25. doi: 10.1097/MBP.0b013e3280f813d0.'}, {'pmid': '16410738', 'type': 'BACKGROUND', 'citation': 'Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. doi: 10.1097/01.mbp.0000189788.05736.5f.'}, {'pmid': '16702826', 'type': 'BACKGROUND', 'citation': 'Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT). Blood Press Monit. 2006 Jun;11(3):165-71. doi: 10.1097/01.mbp.0000209078.17246.34.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization, UNICEF. Global Strategy for Infant and Young Child Feeding, Geneva: WHO, 2003: 1-4, 7-9.'}]}, 'descriptionModule': {'briefSummary': "Objective: It is widely accepted that breastfeeding (AS) is superior to other forms of nutrition in the first six months of life. Breastmilk contains nutrient items in appropriate quantities and a high bioavailability according to the needs of each baby. The United Nations Children's Fund (UNICEF) and the World Health Organization (WHO) recommend that babies take AS alone and then continue to feed on AS with up to two years of age, with appropriate supplementary nutrition, during the first six months of life.\n\nEven in the hottest climates, breastfeeding babies have been shown to have no additional nutrient or fluid requirements for the first six months, including water. In the first 6 months of breastfeeding with breast milk alone (YAS), the incidence of many diseases, especially infectious diseases, decreases and the brain development is better.\n\nDespite its numerous benefits, mother milk is not utilized in our country sufficiently. According to the Turkish Demographic and Health Survey (TNSA), the rate of breastfeeding in Turkey was 91.8% in Turkey, while the proportion of babies fed only breast milk in the first 6 months was 30.1%.\n\nInfants related deaths, otitis media, lower respiratory tract infections, gastroenteritis, obesity were more common in children who were fed formula milk compared to children who were fed breast milk during the first year of life. Obesity can reduce insulin resistance and hypertension risks later in life.\n\nAccording to the research done by Kramer and his colleagues on 13889 children, no effect of breastfeeding on physical development, obesity and hypertension was found.\n\nIn this study, whether breast feeding was associated with otitis media in the first year, lower respiratory tract infection, gastroenteritis; in the first 5 years of age, obesity and hypertension.", 'detailedDescription': "Method: This descriptive study will be conducted by Gaziantep Şahinbey Bağlarbaşı ASM, a 5-year-old children who applied between 01.10.2017 - 04.04.2018, with their weight and blood pressure measurements and their parents' questionnaires. Approximately 500 children will be taken to work. Informed consent is obtained from the parents of the patients who will be employed, and verbal consent is given from the children. Those who do not give their approval will not be included in the study. People with a known congenital disease, those with no birth week between 38 and 42 and a birth weight between 2500 and 4000 grams will not be included in the study.\n\nThe length measurement shall be made on a fixed scale, with the back of the head on a flat surface, with the head perpendicular, and with the eyes vertically facing (Frankfurt plane), the distance between the top of the head and the soles of the feet shall be a fixed scale or gauge. Blood pressure measurement will be measured by a digital blood pressure meter from the left and right hand (M6; Omron Healthcare).\n\nMeasurements of height, weight and hemoglobin in the past ages of the subjects taken in the study group will be taken from the computer programs used in the family medicine system. Percentile values of measurements belonging to each age group will also be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5 year old kids', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being at the age of 5\n* birth weight between 2500 and 4000 grams\n* birth week is between 38-42 weeks\n\nExclusion Criteria:\n\n* Not being at the age of 5\n* birth week is not between 38-42 weeks\n* birth weight between 2500 and 4000 grams\n* having a serious illness e.g. cerebral palsy'}, 'identificationModule': {'nctId': 'NCT03337893', 'briefTitle': 'Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases', 'orgStudyIdInfo': {'id': '307'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breastfed', 'description': 'The kids who breastfed', 'interventionNames': ['Diagnostic Test: blood pressure']}, {'label': 'non-breastfed', 'description': 'The kids who did not breastfed', 'interventionNames': ['Diagnostic Test: blood pressure']}], 'interventions': [{'name': 'blood pressure', 'type': 'DIAGNOSTIC_TEST', 'description': 'it will be done both right and left arms', 'armGroupLabels': ['Breastfed', 'non-breastfed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep Sahinbey Baglarbasi Family Health Center', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yildiz Atadag', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Yildiz Atadag', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}