NCT06048562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

September 16, 2023

Last Update Submit

September 16, 2023

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • evaluate hypertrophic cardiomyopathty in IDM

    1 year

Study Arms (1)

idm

EXPERIMENTAL

evaluation idm for cardiomyopathy

Diagnostic Test: echocardiography

Interventions

echocardiographyDIAGNOSTIC_TEST

evaluation idm for cardiomyopathy by echo

idm

Eligibility Criteria

Age6 Hours - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all infants of diabetic mothers were admitted at NICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelkareem

Asyut, 17155, Egypt

Location

Related Publications (3)

  • Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.

    PMID: 16946226BACKGROUND

  • [3] Correa A, Gilboa SM, Besser LM, Botto LD, Moore CA, Hobbs CA, etal, Diabetes mellitus and birth defects. Obstetric Anesthesia Digest. 2009 Mar 1;29(1):40-1.

    BACKGROUND

  • Hunt KJ, Schuller KL. The increasing prevalence of diabetes in pregnancy. Obstet Gynecol Clin North Am. 2007 Jun;34(2):173-99, vii. doi: 10.1016/j.ogc.2007.03.002.

    PMID: 17572266RESULT

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assuit university

Study Record Dates

First Submitted

September 16, 2023

First Posted

September 21, 2023

Study Start

March 20, 2019

Primary Completion

October 20, 2020

Study Completion

October 20, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)