Infant of Diabetic MotherNCT06111157
Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital
An observational study of Infant of Diabetic Mother, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant of Diabetic Mother
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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 .
Who may be able to join
- The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .
Who cannot join
- Babies born to non diabetic mothers .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital
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.
Read the 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 .
- Conditions
- Infant of Diabetic Mother
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital
Mesure weight in kelograms
Measured: Baseline
Determine clinical spectrum of infants of diabetic mothers
Mesure height in centimeters
Measured: baseline
Determine clinical spectrum of infants of diabetic mothers
Mesure head circumference in centimeters
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infant of Diabetic MotherStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Nasser Mahrous Danial, Assiut University
- Investigators
- Safwat Mohamed Abdel-aziz, Assistant professor, Study director, Assiut UniversityShimaa Kamal Mohamed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111157
- Sponsor's protocol ID
- Infants of diabetic mothers
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35633259Ornoy 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.
PubMed 33803995Malaza 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.
PubMed 36078559Akbariasbagh 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.
PubMed 28282706Kc 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.
PubMed 26045324Weintrob 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.
PubMed 8887019[7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT06111157
- Acronym / sponsor ID
- Infants of diabetic mothers
- Conditions
- Infant of Diabetic Mother
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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 .
Key inclusion criteria (1 listed)
- The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .
Key exclusion criteria (1 listed)
- Babies born to non diabetic mothers .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 height in centimeters
Determine clinical spectrum of infants of diabetic mothers
Time frame: baseline
Mesure head circumference in centimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 35633259Singh 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.
- Background: PubMed 33803995Ornoy 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.
- Background: PubMed 36078559Malaza 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.
- Background: PubMed 28282706Akbariasbagh 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.
- Background: PubMed 26045324Kc 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.
- Background: PubMed 8887019Weintrob 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.
- Background[7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safwat Mohamed Abdel-aziz, Assistant professor study director
Assiut University
Shimaa Kamal Mohamed, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Infant of Diabetic Mother, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Nasser Mahrous, Bachelor's (01286601551, drdina19972015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111157, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.