Infant of Diabetic MotherNCT05050058
Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
An observational study of Infant of Diabetic Mother, run by Marwa Mohamed Farag at 1 site in Egypt.
Trial summary
The aim of this work was to: 1. Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns. 2. Determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers Read more about this study
- Who is it for?
- Ages 0 to 7 days
- Conditions the study is for
- Infant of Diabetic Mother
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2020to 20 Jun 2021
- 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 0 to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: The study was conducted on 50 neonates admitted to the neonatal intensive care unit in Alexandria University Children's Hospital. This study included two groups: Group Ι: Include 25 neonates born to diabetic mother Group II: Include 25 neonates born to non-diabetic mothers as a control group (reference group).
Who may be able to join
- Infant of diabetic mother (IDM) (pregestational and gestational diabetes) born in Alexandria University Children 's Hospital (AUCH) whatever their weight or their gestational age
Who cannot join
- Neonates aged more 7 days.
- Patient born outside the tertiary center of Alexandria University Children 's Hospital.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
The aim of this work was to:
- Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.
- Determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers
- Conditions
- Infant of Diabetic Mother
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates born to diabetic mothers | Not described | |
| Neonates born to non-diabetic mothers (control) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of incidence of congenital heart disease in infants of diabetic mothers
This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.
Measured: First week
Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)
This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study for assessments of PDA and PFO in infants of diabetic mothers in comparison with healthy controls.
Measured: First two months of life
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following:
- Left ventricular end systolic diameter (LVDs).
- Left ventricular end diastolic diameter (LVDd).
- Inter ventricular septal diameter (IVSd).
- Left ventricular posterior wall thickness during diastole (LVPWd).
- Left ventricular posterior wall thickness during systole (LVPWs) those measures are compared in infant of diabetic mothers and healthy controls.
Measured: First two months of life
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following:
- Ejection fraction (EF) .
- Fractional shortening (FS). those measures are compared in infant of diabetic mothers and healthy controls.
Measured: First two months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start8 Mar 2020
- Primary completion12 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant of Diabetic MotherStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Asmaa MR Emara, MBBCh, Principal investigator, Faculty of Medicine, Alexandria University, EgyptIman M Marzouk, PhD, Study director, Faculty of Medicine, Alexandria University, EgyptAly M Abdel-Mohsen, PhD, Study director, Faculty of Medicine, Alexandria University, EgyptMarwa M Farag, PhD, Study chair, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050058
- Sponsor's protocol ID
- 0106399
- Status last verified
- Nov 2022
- First submitted
- 10 Sep 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.
PubMed 20451803
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
- ClinicalTrials.gov ID
- NCT05050058
- Acronym / sponsor ID
- 0106399
- Conditions
- Infant of Diabetic Mother
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marwa Mohamed FaragUniversity, hospital or other
- Study start
- 8 Mar 2020 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 20 Sep 2021 (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.
The aim of this work was to:
- Evaluate the use of echocardiography in the assessment of hemodynamic stability in newborns.
- Determine the prevalence of congenital heart diseases or any cardiac abnormalities in infants born to diabetic mother in relation to the glycemic control of their mothers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates born to diabetic mothers | – | – |
| Neonates born to non-diabetic mothers (control) | – | – |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study was conducted on 50 neonates admitted to the neonatal intensive care unit in Alexandria University Children's Hospital. This study included two groups: Group Ι: Include 25 neonates born to diabetic mother Group II: Include 25 neonates born to non-diabetic mothers as a control group (reference group).
Key inclusion criteria (1 listed)
- Infant of diabetic mother (IDM) (pregestational and gestational diabetes) born in Alexandria University Children 's Hospital (AUCH) whatever their weight or their gestational age
Key exclusion criteria (2 listed)
- Neonates aged more 7 days.
- Patient born outside the tertiary center of Alexandria University Children 's Hospital.
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
Detection of incidence of congenital heart disease in infants of diabetic mothers
Time frame: First week
This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study.
Hemodynamic significance of patent ductus arteriosus (PDA)and patent Foramen Ovale (PFO)
Time frame: First two months of life
This was done using echocardiography: two-dimensional study, color Doppler, pulsed and continuous wave Doppler as well as m-mode study for assessments of PDA and PFO in infants of diabetic mothers in comparison with healthy controls.
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
Time frame: First two months of life
Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following: * Left ventricular end systolic diameter (LVDs). * Left ventricular end diastolic diameter (LVDd). * Inter ventricular septal diameter (IVSd). * Left ventricular posterior wall thickness during diastole (LVPWd). * Left ventricular posterior wall thickness during systole (LVPWs) those measures are compared in infant of diabetic mothers and healthy controls.
Assessment of left ventricular dimensions in infants of diabetic mothers in comparison to healthy controls.
Time frame: First two months of life
Using M-mode images under guidance of two dimensional echocardiography in parasternal long axis view was done for all participants measuring of the following: * Ejection fraction (EF) . * Fractional shortening (FS). those measures are compared in infant of diabetic mothers and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 20451803Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.
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.
Asmaa MR Emara, MBBCh principal investigator
Faculty of Medicine, Alexandria University, Egypt
Iman M Marzouk, PhD study director
Faculty of Medicine, Alexandria University, Egypt
Aly M Abdel-Mohsen, PhD study director
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant of Diabetic Mother, run by Marwa Mohamed Farag at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of incidence of congenital heart disease in infants of diabetic mothers (time frame: First week). The study lists 4 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 NCT05050058, which also lists 1 linked publication.
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 30 Nov 2022.