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Clinical Trials/NCT06111157
NCT06111157
Not yet recruiting
Not Applicable

Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital

Assiut University0 sites100 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant of Diabetic Mother
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

The global incidence of diabetes mellitus including diabetes of pregnant women is on the rise . Diabetes during pregnancy has been associated with several maternal and fetal problems . Diabetes 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 . While pregestational diabetes is the condition in which a woman with diabetes ( type 1 or commonly type 2 ) before the onset of pregnancy . Both 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 . Inspite 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 . Fetal 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 . This infant may experience asphyxia , respiratory distress , hypoglycemia or hyperglycemia , hyperinsulinemia , hypocalcemia , hypomagnesemia , hyperbilirubinemia , polycythemia and anemia . Caudal regression syndrome , anencephaly , microcephaly , hydrocephalus , spina bifida are also complications of diabetes mellitus in pregnancy . Both 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 . It has been found that there is increased rate of obesity , impaired glucose intolerance or diabetes mellitus in the childhood and adolescence . Mechanisms of diabetic induced damage in pregnancyare related to maternal and fetal hyperglycemia ,enhanced oxidation status , epigenetic changes and other less defined pathogenic mechanisms . Uncontrolled diabetes has profound effects on embryogenesis , organogenesis , and fetal and neonatal growth . The severity of complications is higher with earlier onset of gestational diabetes mellitus and inversely correlated with the degree of glycemic control . Early initiation of gestational diabetes mellitus might even cause some increase in the rate of congenital malformations . Tight glycemic control prior to conception and during pregnancy can prevent an excess rate of congenital malformations ,macrosomia , birth trauma and neonatal respiratory distress syndrome .

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
April 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Nasser Mahrous Danial

Principle investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .

Exclusion Criteria

  • Babies born to non diabetic mothers .

Outcomes

Primary Outcomes

Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital

Time Frame: Baseline

Mesure weight in kelograms

Determine clinical spectrum of infants of diabetic mothers

Time Frame: baseline

Mesure head circumference in centimeters

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