18-month developmental follow-up after mitochondrial donation
Mitochondrial Donation: An 18 Month Outcome Study.
Newcastle-upon-Tyne Hospitals NHS Trust · NCT04113447
This project looks to see if children born after mitochondrial donation show typical neurodevelopment at 18 months using a standard developmental test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Sex | Female |
| Sponsor | Newcastle-upon-Tyne Hospitals NHS Trust (other) |
| Locations | 1 site (Newcastle upon Tyne, Tyne & Wear) |
| Trial ID | NCT04113447 on ClinicalTrials.gov |
What this trial studies
This observational project will record fetal and postnatal health and development for children conceived using mitochondrial donation. At around 18 months' corrected age each child will undergo the Bayley-III developmental assessment administered by experts to measure cognitive, language, and motor development. Pregnancy, delivery, and early-life clinical data will also be collected from medical records with parental consent. The study tests the hypothesis that neurodevelopment at 18 months in these children is within normal ranges.
Who should consider this trial
Good fit: Ideal participants are women with a confirmed mtDNA mutation who are eligible for mitochondrial donation under HFEA licensing, consent to the protocol, and agree to provide pregnancy and child follow-up data to 18 months corrected age.
Not a fit: Patients who decline mitochondrial donation, cannot commit to the follow-up schedule, or are unwilling to share pregnancy or child health information would not benefit from enrollment in this project.
Why it matters
Potential benefit: If results show normal development, the findings could reassure families and regulators about the early neurodevelopmental safety of mitochondrial donation.
How similar studies have performed: Mitochondrial donation is a novel clinical approach with only small case series and limited short-term follow-up reported, so comprehensive 18-month outcome data remain scarce.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Newcastle upon Tyne, Tyne & Wear
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne & Wear, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitochondrial Diseases