Clinical Trial

Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics (NeuroToP - a COPANA Follow up)

Study acronym: NeuroToP
Enrolling by Invitation
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Summary
Fundamental aspects of both neurological and reproductive function are established in fetal life, and there is a present increased awareness of the potential effects of fetal exposures on neurodevelopmental and reproductive health of offspring. Experimental and epidemiological research studies strongly suggest that paracetamol and NSAID are endocrine disruptive in the fetus, which could increase the risks of some neurodevelopmental, reproductive, and urogenital disorders. In recent years, there has been an increasing rate of neurodevelopmental disorders such as ADHD and autism. The original cohort, the Copenhagen Analgesic Study (COPANA), is the first prospective human study designed primarily to assess the effect of fetal exposure to mild analgesics on male and female reproductive function. If the same children are examined with relevant neurobehavioral testing during mid-childhood, the study design allows the investigators to assess the effect of mild analgesics as well as other EDCs on neurodevelopmental health.
Trial Details
NCT Number NCT07316387
Lead Sponsor Rigshospitalet, Denmark
Conditions Gonad Regulating Hormone Adverse Reaction, Analgesic Adverse Reaction, Developmental Disability, Adhd, Autism Spectrum Disorder, Language Development
Enrollment 685 participants
Start Date 2024-05-27
Primary Completion 2028-05-27 (estimated)
Study Completion 2028-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-01-05