Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT06048562
Collaborator
(none)
50
1
1
43
1.2

Study Details

Study Description

Brief Summary

To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: echocardiography
N/A

Detailed Description

Diabetes is the most common endocrine disorder complicating pregnancy. Incidence of both type-I and type-II diabetes is increasing, throughout the world. As the incidence of diabetes continues to rise and increasingly affects individuals of all ages including young adults and children, women in child bearing age are at increased risk of diabetes during pregnancy [1].

The type 1 diabetes around the time of conception produces marked risk of embryopathy (neural tube defects, cardiac defects, and caudal regression syndrome) as these mother have high glycosylated hemoglobin at the time of embryogenesis (around 6-8 weeks of gestation) rather than IDM that are born to type 2 diabetes mothers who have macrosomia and other milder problems. The mothers who have been diagnosed as severe and unstable type1 diabetes in the later part of gestation have high chances of neonate being more affected with intrauterine growth restriction, asphyxia, and fetal death [2] and [3].

Due to the teratogenic effect of maternal diabetes, the reported incidence of congenital malformations among the newborns of diabetic mothers is five times greater than that of the general population [4].

Cardiac malformations are one of the most common types of these malformations which occur in about 8.5% of cases that is about 10 times more than its incidence in normal population (0.8%) [5].

Fetuses exposed to maternal hyperglycemia and hyperinsulinism, are prone to develop hypertrophic cardiomyopathy. It primarily affects the inter-ventricular septum, but can extend to the myocardium in more severe cases. Although the perinatal mortality rates associated with diabetes in pregnancy have declined considerably during the past eight decades and are now near those in the general population, it is only through continuing vigilance that such advances can be maintained. Both fetal and neonatal deaths occurred with increased frequency in diabetic pregnancies before the advent of modern management methods, and fetal deaths nationwide continue to be significantly higher among diabetic than non-diabetic pregnancies [6].

The most recent available data indicate that the relative risk of stillbirth in pregnancies complicated by type 1 diabetes (compared to the general population) is 2.9-4.3 folds, and for type 2 diabetes 2.5-4.5 fold [7].

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery.To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Oct 20, 2020
Actual Study Completion Date :
Oct 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: idm

evaluation idm for cardiomyopathy

Diagnostic Test: echocardiography
evaluation idm for cardiomyopathy by echo

Outcome Measures

Primary Outcome Measures

  1. evaluate hypertrophic cardiomyopathty in IDM [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Hours to 30 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all infants of diabetic mothers were admitted at NICU
Exclusion Criteria:
  • NO

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Abdelkareem Assiut Egypt 17155

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Abdelkareem, Assuit university, Assiut University
ClinicalTrials.gov Identifier:
NCT06048562
Other Study ID Numbers:
  • hypertrophic cardiomyopathy
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023