SSRI's during pregnancy and lactation. Individualized care with drug analysis: Measurements of antidepressants In the Neonate anD breast milk.
Withdrawn
- Conditions
- depression1002892010037176
- Registration Number
- NL-OMON44977
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 180
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
Syndromal or chromosomal abnormalities.
Congenital metabolic disease.
Severe hepatic and renal insufficiency.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The relationship between SSRI drug levels and clinical effects after exposure<br /><br>to SSRI*s during pregnancy and lactation in (pre)term infants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The relationship between neonatal drug levels and long term developmental<br /><br>outcome, the influence of co-medication and the relationship between NAP and<br /><br>cortisol levels.</p><br>