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ENROLLING BY INVITATION
NCT07316387

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

OBSERVATIONAL

Enrollment

685

Start Date

2024-05-27

Completion Date

2028-05-27

Last Updated

2026-01-05

Healthy Volunteers

Yes

Locations (1)

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, Denmark