- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03603301
Vision in Children Born to Opioid-dependent Methadone-maintained Mothers (VINCH)
Study Overview
Status
Detailed Description
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.
The data will be added to the existing database for these children, and the test results correlated with the results found at birth and at six months, and with the any known drug exposure of each child.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Glasgow, United Kingdom, G51 4TF
- Children's Clinical Research Facility (CRF), Queen Elizabeth University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- congenital ocular abnormality; significant neonatal illness
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
presence of strabismus, nystagmus, reduced acuity, significant refractive error
Time Frame: 2 years
|
natural history of visual abnormalities following in utero exposure to methadone +/- other drugs
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation of abnormality or normality with prenatal drug exposure
Time Frame: 2 years
|
to map visual findings to the known prenatal drug exposure and infant visual findings for each child
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth Hamilton, PhD, NHS Greater Glasgow & Clyde
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN16OP130p
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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