Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 8:11 AM
Study NCT ID:
NCT06111157
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2023-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-10-14', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital", 'timeFrame': 'Baseline', 'description': 'Mesure weight in kelograms'}, {'measure': 'Determine clinical spectrum of infants of diabetic mothers', 'timeFrame': 'baseline', 'description': 'Mesure height in centimeters'}, {'measure': 'Determine clinical spectrum of infants of diabetic mothers', 'timeFrame': 'baseline', 'description': 'Mesure head circumference in centimeters'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant of Diabetic Mother']}, 'referencesModule': {'references': [{'pmid': '35633259', 'type': 'BACKGROUND', 'citation': 'Singh S, Yadav M. Gestational Diabetes Mellitus among Pregnant Women Delivering in a Tertiary Care Hospital: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2022 Mar 11;60(247):229-233. doi: 10.31729/jnma.7304.'}, {'pmid': '33803995', 'type': 'BACKGROUND', 'citation': 'Ornoy A, Becker M, Weinstein-Fudim L, Ergaz Z. Diabetes during Pregnancy: A Maternal Disease Complicating the Course of Pregnancy with Long-Term Deleterious Effects on the Offspring. A Clinical Review. Int J Mol Sci. 2021 Mar 15;22(6):2965. doi: 10.3390/ijms22062965.'}, {'pmid': '36078559', 'type': 'BACKGROUND', 'citation': 'Malaza N, Masete M, Adam S, Dias S, Nyawo T, Pheiffer C. A Systematic Review to Compare Adverse Pregnancy Outcomes in Women with Pregestational Diabetes and Gestational Diabetes. Int J Environ Res Public Health. 2022 Aug 31;19(17):10846. doi: 10.3390/ijerph191710846.'}, {'pmid': '28282706', 'type': 'BACKGROUND', 'citation': 'Akbariasbagh P, Shariat M, Akbariasbagh N, Ebrahim B. Cardiovascular Malformations in Infants of Diabetic Mothers: A Retrospective Case-Control Study. Acta Med Iran. 2017 Feb;55(2):103-108.'}, {'pmid': '26045324', 'type': 'BACKGROUND', 'citation': 'Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.'}, {'pmid': '8887019', 'type': 'BACKGROUND', 'citation': 'Weintrob N, Karp M, Hod M. Short- and long-range complications in offspring of diabetic mothers. J Diabetes Complications. 1996 Sep-Oct;10(5):294-301. doi: 10.1016/1056-8727(95)00080-1.'}, {'type': 'BACKGROUND', 'citation': '[7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."'}]}, 'descriptionModule': {'briefSummary': "Determine spectrum of clinical presentations and complications associated with maternal diabetes mellitus in their newborns attending and admitted to Neonatal Intensive Care Unit of Assiut University Children's Hospital.", 'detailedDescription': 'The global incidence of diabetes mellitus including diabetes of pregnant women is on the rise .\n\nDiabetes during pregnancy has been associated with several maternal and fetal problems .\n\nDiabetes during pregnancy include gestational diabetes which is defined as carbohydrate intolerance of varying degrees with hyperglycemia starting during pregnancy ,generally develops in the second half of pregnancy .\n\nWhile pregestational diabetes is the condition in which a woman with diabetes ( type 1 or commonly type 2 ) before the onset of pregnancy .\n\nBoth gestational and pregestational diabetes are associated with increased rates of adverse maternal and neonatal outcomes . Adverse outcomes are more common with pregestational diabetes compared to gestational diabetes mellitus ; although , conflicting results have been reported .\n\nInspite the huge progress in the treatment of diabetes mellitus , Investigators are still in the situation that both gestational and pregestational diabetes impose an additional risk to the embryo , fetus , and course of pregnancy Pregestational diabetes mellitus increases the rate of congenital malformations , especially cardiac such as Patent foramen ovale , hypertrophic cardiomyopathy , Atrial septal defect , ventricular septal defect .\n\nFetal macrosomia is a common adverse effect on the infant outcomes . It increases the risk of shoulder dystocia , clavicle fractures , brachial plexus injury , which increase the rate of admission to the neonatal intensive care unit .\n\nThis infant may experience asphyxia , respiratory distress , hypoglycemia or hyperglycemia , hyperinsulinemia , hypocalcemia , hypomagnesemia , hyperbilirubinemia , polycythemia and anemia .\n\nCaudal regression syndrome , anencephaly , microcephaly , hydrocephalus , spina bifida are also complications of diabetes mellitus in pregnancy .\n\nBoth gestational and pregestational diabetes may also cause various motor and behaviouralneurodevelopmental problems including an increased incidence of attention deficit hyperactivity disorder and autism spectrum disorder .\n\nIt has been found that there is increased rate of obesity , impaired glucose intolerance or diabetes mellitus in the childhood and adolescence .\n\nMechanisms of diabetic induced damage in pregnancyare related to maternal and fetal hyperglycemia ,enhanced oxidation status , epigenetic changes and other less defined pathogenic mechanisms .\n\nUncontrolled diabetes has profound effects on embryogenesis , organogenesis , and fetal and neonatal growth .\n\nThe severity of complications is higher with earlier onset of gestational diabetes mellitus and inversely correlated with the degree of glycemic control .\n\nEarly initiation of gestational diabetes mellitus might even cause some increase in the rate of congenital malformations .\n\nTight glycemic control prior to conception and during pregnancy can prevent an excess rate of congenital malformations ,macrosomia , birth trauma and neonatal respiratory distress syndrome .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .\n\nExclusion Criteria:\n\n* Babies born to non diabetic mothers ."}, 'identificationModule': {'nctId': 'NCT06111157', 'briefTitle': "Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital", 'orgStudyIdInfo': {'id': 'Infants of diabetic mothers'}}, 'contactsLocationsModule': {'centralContacts': [{'name': "Dina Nasser Mahrous, Bachelor's", 'role': 'CONTACT', 'email': 'drdina19972015@gmail.com', 'phone': '01286601551'}, {'name': 'Nafisa Refat Hassan, Professor', 'role': 'CONTACT', 'email': 'nrefat@aun.edu.eg', 'phone': '01003472082'}], 'overallOfficials': [{'name': 'Safwat Mohamed Abdel-aziz, Assistant professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Shimaa Kamal Mohamed, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Dina Nasser Mahrous Danial', 'investigatorAffiliation': 'Assiut University'}}}}