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临床试验/NCT03603301
NCT03603301Unknown不适用

Vision in Children Born to Opioid-dependent Methadone-maintained Mothers

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
presence of strabismus, nystagmus, reduced acuity, significant refractive error

研究概览

简要总结

The investigators will re-investigate 150 children studied extensively in the past. 100 of these children were born to mothers prescribed methadone during their pregnancy because of opiate dependency, and 50 were comparison children who were not exposed to drugs. These children were investigated when they were newborn babies, and again when they were six months old, and a quarter of the drug-exposed babies had problems with their eyesight, whilst very few of the comparison children has eyesight problems. The investigators would like to see whether the eyesight problems are still present in the children now that they are older. Because they are older, more detailed testing can be undertaken which will help to understand how drug exposure in the womb may have affected their eyesight. The investigators will recruit new, comparison children to the study to match the number of comparison children with the number of drug-exposed children. The findings will be relevant and important when advising mothers on drug use - both prescribed and illicit - when they are pregnant.

详细描述

Multiple researchers across the world over many decades have noted eyesight problems in children born to mothers who use drugs during pregnancy. From our earlier work on this group of children, we have detailed knowledge of which drugs each mother used, making this group of children uniquely important for understanding the consequences of drug use during pregnancy. Although methadone use in the UK is dropping as heroin misuse falls, there is currently an international epidemic of babies being born to mothers using illicit or prescribed opioid drugs (e.g. methadone, heroin, opiate-based painkillers). These babies may be at risk of the same eyesight problems as this Scottish cohort. Knowing the longer-term consequences and disseminating the findings to relevant international clinical groups could help to alleviate the consequential damage, through better information for mothers and through better and prompter management of affected children.

The study is planned to run for 2 years. It is anticipated that a maximum of 65 drug-exposed children (out of the original 100) will attend, and will therefore aim to also investigate 65 comparison children, as many as possible of whom will belong to the original cohort of 50 comparison children.

Testing will take place in the Children's Clinical Research Facility (CRF), on the campus of the Queen Elizabeth University Hospital and Royal Hospital for Children, Glasgow. A CRF paediatric nurse will recruit, coordinate and administrate the study. They will manage the child's progress through the assessment session, measure height, weight and head circumference, document demographic, social and educational details from the child's carer, and will apply two questionnaires to the carers. Eyesight tests will be done by a specialist paediatric orthoptist, and will include acuity (the smallest letter correctly identified), stereoacuity (perception of depth) and looking for squints or nystagmus (shaking or wobbling of the eyes).

Highly specialised eye tests (eye movement recordings and visual evoked potentials) will also be undertaken.

If any abnormalities are noted from these tests, the child will be given eyedrops to dilate their pupils. All children will be seen by a paediatric ophthalmologist who will look at the back of their eyes, and check whether they need glasses, or whether their glasses are correct. A medical history will be taken. If any problems are noted during the visit (e.g. visual, medical, social), the child will be referred to relevant services after discussion with their carer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • cases: born to opioid-dependent mothers prescribed substitute methadone during pregnancy and delivered after 36 completed weeks' gestation.
  • comparisons: healthy, non drug-exposed infants delivered within the same maternity unit, matched for gestation, birthweight ± 250g and Carstairs deprivation score ± 1; attempted match for smoking

排除标准

  • congenital ocular abnormality; significant neonatal illness

结局指标

主要结局

presence of strabismus, nystagmus, reduced acuity, significant refractive error

时间窗: 2 years

natural history of visual abnormalities following in utero exposure to methadone +/- other drugs

次要结局

  • correlation of abnormality or normality with prenatal drug exposure(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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