18-month developmental follow-up after mitochondrial donation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Newcastle upon Tyne Hospitals NHS Foundation Trust
  Newcastle upon Tyne, Tyne & Wear, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.