Medical scientific research

We want to continue to improve the care for, and chances of newborns. We contribute to this by continuing to perform new studies. In order to do this, we need your help. You may be approached with the request to participate in ongoing research in our unit before and/or after the birth of your child/children.

Please realise that not all, but only some of the studies will be relevant for  your child. In some cases, perhaps none of the studies will be relevant. If your child is eligible for participation in one of the studies, the attending physician or research will speak with you and you will also be given written information regarding that specific study.


The studies that are being carried out in the neonatology department can roughly be divided into 2 groups

1) Studies that are performed at birth/ 1st care for the baby by the paediatrician

If it is at all possible, for example because you have been admitted to the Geboortehuis Leiden during an earlier pregnancy, these studies will already be discussed with you in advance so that you have the time to think about it quietly prior to giving your consent. On other occasions, it has not been possible to discuss this in advance in which case the medical ethics assessment committee approves the request that consent be requested in retrospect. This will only be the case in studies which are comparing regular care and / or where absolutely no risk for, or burden to the baby can be expected as a result of participation.

Currently ongoing studies in this group are:

ABC3 (premature babies with gestational age of 24 to 30 weeks)

Cultus trial (premature babies with gestational age of 24 to 30 weeks): information follows


2) Studies performed during the admission to the unit

The attending physician/ researcher will discuss this with you as soon as the situation arises indicating that your child might be eligible for participation.

Currently ongoing studies in this group are:

BeNeDuctus studie (prematuren met zwangerschapsduur 24 tot 28 weken)

Epo-4-Rhesus (alle baby's met rhesusziekte)

Consent

If you have consented to participating in one of the aforementioned studies and you wish to withdraw this consent, that is always possible. Please inform your attending physician or the researcher responsible for this study of your decision as soon as possible.

Studies are also performed using the information that is kept by way of standard regarding the daily care and treatment in your baby’s file (retrospective (file) studies). The information and data are anonymised and cannot be traced to the patient. In principle, use of this information does not require prior consent from the parents. If you do not want this information to be used, please inform your attending physician.

Additional information on this can be found in our patient information leaflet on medical scientific research on newborn infants. General information on medical scientific research from the Dutch Ministry of Health, Welfare and Sport can be found in this leaflet.