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

The prevalence of antidepressant use during pregnancy in The Netherlands is
2-3% and concerns mainly selective serotonine reuptake inhibitors (SSRI*s).
Approximately 30% of prenatally exposed neonates develop neonatal adaptation
problems (NAP),), which are usually mild and self limiting. Currently, it is
not clear which neonates are at risk to develop NAP and if there is a relation
with the SSRI concentration in the blood of the neonate. Possible factors
which can have an effect on NAP are for example gestational age, lactation and
maternal co-medication (e.g. benzodiazepines). Although long term effects seem
to be generally favourable, the relationship with neonatal drug levels is
unknown. Also, there might be a relationship between NAP and stress in the
neonate and therefore a relationship between neonatal cortisol levels and NAP.

With this research project we will investigate the relationship between SSRI
concentration in the (pre)term neonate and clinical short and long term effects
on the neonate after exposure to SSRI*s during pregnancy and lactation.
Furthermore, the influence of co-medication, as well as the relationship
between NAP and cortisol will be investigated. We aim to optimize providing
information to health care professionals and parents by analyzing the
relationship between SSRI-concentrations and short and long term effects in the
neonate.

This is a prospective observational cohort study of the most commonly used
SSRI*s during pregnancy and lactation without any study related invasive
interventions.

This observational study concerns an existing situation, namely exposure to
SSRI*s during pregnancy and lactation. A maximum of 3 mL of blood will be
obtained from the neonate, divided over 4 sampling moments, using the dried
blood spot method. We tend to combine blood sampling with routine blood
analysis if applicable. The risk associated with participation can be
considered negligible and the burden can be considered minimal. Due to the
nature of the study it is not feasible to conduct the research in another group
than (pre)term infants.

Also saliva will be analysed at birth and at the age of 3 months and 1 year.

Currently, there is no standard follow up procedure for SSRI exposed infants.
With respect to investigate the long term effects on children after exposure to
SSRI*s during pregnancy and lactation, we will invite participating neonates
for follow up at the age of 3 months, 1 and 2 years. Development will be
investigated by a physiotherapist and at the age of 2 years also by a
psychologist.

During pregnancy, blood will be obtained 1 times of the mother
During lactation, the mother will be asked to donate a small amount of breast
milk 3 times for analysis. Also blood will be obtained at these moments.