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NCT07316387: NeuroToP
Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics (NeuroToP - a COPANA Follow up)
trial in Gonad Regulating Hormone Adverse Reaction in 685 participants. Enrolling by invitation.
27 May 2028
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 685 |
| Start date | 27 May 2024 |
| Primary completion | 27 May 2028 |
| Estimated completion | 27 May 2028 |
| Sites | 1 location across Denmark |
Conditions studied
- Gonad Regulating Hormone Adverse Reaction — all drugs for Gonad Regulating Hormone Adverse Reaction →
- Analgesic Adverse Reaction — all drugs for Analgesic Adverse Reaction →
- Developmental Disability — all drugs for Developmental Disability →
- Adhd — all drugs for Adhd →
Sponsor
Rigshospitalet, Denmark
Who can join
Adults 2 to 6, any sex, with Gonad Regulating Hormone Adverse Reaction or Analgesic Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07316387
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07316387 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 5 January 2026
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