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Mitochondrial Donation: An 18 Month Outcome Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113447
Recruitment Status : Unknown
Verified October 2020 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : October 2, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Study Description
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Brief Summary:
The Investigator proposes to record the fetal and postnatal development of children conceived using Mitochondrial Donation (MD) and to perform expert assessment of development at 18 months (corrected for gestational age) using the internationally validated Bayley-III developmental assessment tool.

Condition or disease Intervention/treatment
Mitochondrial Diseases Other: observational

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: observational
    observational

Outcome Measures
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Primary Outcome Measures :
  1. A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected [ Time Frame: 18 months ]
    The Bayley Scale of Infant and Toddler Development, Third Edition (Bayley III) measures physical, motor, sensory, and cognitive development in babies and young children. The scale encompasses five developmental domains - cognitive, language, motor, social-emotional and adaptive behaviour. The structure of the Bayley-III Scales allows clinicians to administer each of the five scales (cognitive, language-receptive and expressive, motor-fine and gross, social-emotional, and adaptive behaviour) independent of others. Higher scores in each scale indicates more advanced development. Performance is summarised via scaled scores for each subtest, and composite scores for each scale, together with percentile ranks, developmental age equivalents, and growth scores. Discrepancy information is used to determine whether there are significant differences between a child's abilities in the domains measured, and how prevalent these differences are in the norming sample. A total score is not provided.


Secondary Outcome Measures :
  1. 1)Normal hearing as assessed by formal audiology, [ Time Frame: 18 months ]
    Formal Audiology

  2. 2)Normal vision as assessed by ophthalmologist [ Time Frame: 18 months ]
    Ophthalmology Assessment


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with mitochondrial disease undergoing mitochondrial donation treatment
Criteria

Inclusion Criteria:

Women will only be eligible if they meet all of the following criteria.

  • Women with confirmed mtDNA mutation
  • Suitable to undergo Mitochondrial Donation as a treatment (in line with HFEA license)
  • Informed Consent for the study obtained before Mitochondrial Donation treatment commences
  • Ability and willingness to adhere to the protocol including evaluation schedule
  • Willingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

Exclusion Criteria:

Women will not be eligible if they meet any of the following criteria

  • Declined Mitochondrial Donation as a treatment (in line with HFEA license)
  • Inability or unwillingness to adhere to the protocol including evaluation schedule
  • Unwillingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
Contact: Robert McFarland    0191 2820340    robert.mcfarland@ncl.ac.uk   
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Wellcome Trust
More Information
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04113447    
Other Study ID Numbers: 8075
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitochondrial Diseases
Metabolic Diseases