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

NCT03603301 | Unknown

• 1 other identifier: GN16OP130p
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vision Disorders; Strabismus; Nystagmus; Binocular Vision Disorder

Outcome Measures

Primary Outcomes (1)

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

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

  2 years

Secondary Outcomes (1)

• correlation of abnormality or normality with prenatal drug exposure

  2 years

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

100 drug-exposed neonates and 50 comparison infants, all born between 13/08/2008 and 30/04/2009 at the Princess Royal Maternity in Glasgow, previously recruited to the VIDI study; an additional 50 classroom comparison children.

You may qualify if:

• 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

You may not qualify if:

• congenital ocular abnormality; significant neonatal illness

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Waterloo: collaborator

Study Sites (1)

Children's Clinical Research Facility (CRF), Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (1)

• Hamilton R, Mulvihill A, Butler L, Chow A, Irving E, McCulloch DL, McNeil A, Michael K, Spowart KM, Waterson-Wilson J, Mactier H. Impaired vision in children prenatally exposed to methadone: an observational cohort study. Eye (Lond). 2024 Jan;38(1):118-126. doi: 10.1038/s41433-023-02644-3. Epub 2023 Jul 4.

  PMID: 37402864 DERIVED

MeSH Terms

Conditions

Vision Disorders; Strabismus; Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Study Officials

• Ruth Hamilton, PhD

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: July 27, 2018
• Study Start: July 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)