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SSRI's during pregnancy and lactation. Individualized care with drug analysis: Measurements of antidepressants In the Neonate anD breast milk.

SSRI's during pregnancy and lactation. Individualized care with drug analysis: Measurements of antidepressants In the Neonate anD breast milk. - MIND study: Measurements of antidepressants In the Neonate anD breast milk

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44977
Enrollment
180
Registered
2017-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

depression

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Exposure to SSRI*s in at least the last 4 weeks before delivery or exposure during lactation. Written informed consent from the parents or a legal guardian.

Exclusion criteria

Exclusion criteria: Syndromal or chromosomal abnormalities. Congenital metabolic disease. Severe hepatic and renal insufficiency.

Design outcomes

Primary

MeasureTime frame
The relationship between SSRI drug levels and clinical effects after exposure to SSRI*s during pregnancy and lactation in (pre)term infants.—

Secondary

MeasureTime frame
The relationship between neonatal drug levels and long term developmental outcome, the influence of co-medication and the relationship between NAP and cortisol levels.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)