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NCT07316387Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 5 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
685 (estimated)
First submitted
17 Mar 2025
Start date
27 May 2024
Primary completion date
27 May 2028
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Diseases
Autism
NCT number
NCT07316387

What you commit to

  • Study type: Observational
  • Planned participants: 685
  • From 27 May 2024 to the primary completion date, 27 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe disease in the child

Other

  • Premature birth
  • Postterm birth
  • Twin birth (gemelli)
  • Stillbirth
  • Late abortion

Who the study is looking for

  • \- Participant in the COPANA project

Age in the registry: 2 years to 6 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Growth and Reproduction, Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.