Mitochondrial Donation: An 18 Month Outcome Study.

Mitochondrial Diseases Clinical Trial

Official title:

Mitochondrial Donation: An 18 Month Outcome Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113447
• Other study ID #: 8075
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2020
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Mitochondrial Diseases

Intervention

Other:
• observational
observational

Locations

Country	Name	City	State
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne	Tyne & Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months
Secondary	1)Normal hearing as assessed by formal audiology,	Formal Audiology	18 months
Secondary	2)Normal vision as assessed by ophthalmologist	Ophthalmology Assessment	18 months