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EURAP and Development. A study on behavioral-, cognitive- and motordevelopment of children exposed to valproic acid in utero - a Dutch pilot study in anticipation of the international EURAP/NCEP study (European Register of Antiepileptic Drugs and Pregnancy / Neurocognitive Extension Protocol)

EURAP and Development. A study on behavioral-, cognitive- and motordevelopment of children exposed to valproic acid in utero - a Dutch pilot study in anticipation of the international EURAP/NCEP study (European Register of Antiepileptic Drugs and Pregnancy / Neurocognitive Extension Protocol) - EURAP-NCEP pilot NL

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31656
Enrollment
20
Registered
2008-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism neurodevelopmental disorders

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Definite exposure of the child during the entire period from conception to birth to valproic acid. Age between 6 and 12 years

Exclusion criteria

Exclusion criteria: Family history of developmental delay or significant learning disabilities of the parents Significant pre-, peri- and postnatal neurological co-morbidity of the child Mother-child pairs in whom information cannot be reliably assessed.

Design outcomes

Primary

MeasureTime frame
Efficacy of the study—

Secondary

MeasureTime frame
Full scale, verbal and non verbal IQ Presence or absence of DSM IV diagnosis Deviation from normscores on all other instruments—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)