Mitochondrial Donation: An 18 Month Outcome Study.
ConditionMitochondrial Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorNewcastle-upon-Tyne Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Women with mitochondrial disease undergoing mitochondrial donation treatment
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
observational
Other interventionobservational
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected
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.
Time frame
18 monthsSecondary outcomes
1
1)Normal hearing as assessed by formal audiology,
Formal Audiology
Time frame
18 months2
2)Normal vision as assessed by ophthalmologist
Ophthalmology Assessment
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Newcastle-upon-Tyne Hospitals NHS Trust
Lead sponsor
Wellcome Trust
Collaborator
Source ClinicalTrials.gov