NCT06111157

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
unknown

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

First Submitted

Initial submission to the registry

October 14, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 14, 2023

Last Update Submit

November 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

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

    Mesure weight in kelograms

    Baseline

  • Determine clinical spectrum of infants of diabetic mothers

    Mesure height in centimeters

    baseline

  • Determine clinical spectrum of infants of diabetic mothers

    Mesure head circumference in centimeters

    baseline

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Babies born to non diabetic mothers .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 35633259BACKGROUND
  • 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: 33803995BACKGROUND
  • 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: 36078559BACKGROUND
  • 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: 28282706BACKGROUND
  • 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: 26045324BACKGROUND
  • 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.

    PMID: 8887019BACKGROUND
  • [7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."

    BACKGROUND

Study Officials

  • Safwat Mohamed Abdel-aziz, Assistant professor

    Assiut University

    STUDY DIRECTOR
  • Shimaa Kamal Mohamed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Dina Nasser Mahrous, Bachelor's

CONTACT

Nafisa Refat Hassan, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 14, 2023

First Posted

November 1, 2023

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

November 9, 2023

Record last verified: 2023-11