Mitochondrial Donation: An 18 Month Outcome Study.
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|ClinicalTrials.gov Identifier: NCT04113447|
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment|
|Mitochondrial Diseases||Other: observational|
To record the fetal and postnatal development of children conceived using Mitochondrial Donation and to perform internationally validated Bayley-III developmental assessment tool at 18 months (corrected for gestational age).
The null hypothesis for this research is that children born following the use of Mitochondrial Donation (IVF) techniques have normal neurodevelopment developmental outcomes at 18 months.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Mitochondrial Donation: An 18 Month Outcome Study.|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
- Other: observational
- A normal neurodevelopmental quotient scored using a Bayley-III at 18 months (corrected [ Time Frame: 18 months ]A normal neurodevelopmental quotient scored using a Bayley-III score at 18 months
- 1)Normal hearing as assessed by formal audiology, [ Time Frame: 18 months ]Formal Audiology
- 2)Normal vision as assessed by ophthalmologist [ Time Frame: 18 months ]Ophthalmology Assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113447
|The Newcastle upon Tyne Hospitals NHS Foundation Trust||Recruiting|
|Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP|
|Contact: Robert McFarland 0191 2820340 email@example.com|