Mitochondrial Donation: An 18 Month Outcome Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
A normal neurodevelopmental quotient scored using a Bayley-III ( Bayley Scales of Infant and Toddler Development, Third Edition) at 18 months (corrected
时间窗: 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.
次要结局
- 1)Normal hearing as assessed by formal audiology,(18 months)
- 2)Normal vision as assessed by ophthalmologist(18 months)