Eligibility questions:

  • Can I include a patient on the 14th day of life? Yes, you most certainly can! The study protocol states, that the postnatal age has to be “7-14 days of postnatal age”, which includes the 14th day of life.

Medication questions:

  • How can I get a new number for a stress medication kit?
    Within the SToP-BPD site map you will find four sealed envelopes under the
    “Stress medication Procedures” with the caption “Functional account
    o the CRF to obtain
    stress medication”. If you already have a login account,
    please do not use these envelopes,
    you can obtain a new kit of stress
    medication with your own login!
  • How does the pharmacy recieve new study medication? By randomizing in the eCRF an automated email is generated to the pharmacy of the AMC. They will keep number of how many patients are recruited in your center. As soon as the available study medication kits reach a critical low number, a new stock will be sent to you. However, don't hestitate to email us (stop-bpd@amc.nl) to alarm us and we will contact the pharmacy of the AMC.
  • Can the medication be given enterally? Yes, the study medication can also be given enterally in the same dose and frequency if no intravenous access is available, although administration is preferred intravenously.  
  • Should the weight used to calculate the study medication be adjusted to the actual weight? No, the study medication schedule is calculated on the weight recorded on day of randomization and will not be adjusted during the schedule.

eCRF questions:

·         After I have filled in the allocation page in the eCRF, confirmed that I wanted to randomize this patient and pushed the “save” button, the program gave me the following answer: Randomization number: 0! How can I get a randomization number? Something went wrong during the randomization procedure. Try to “validate” the patient again by pushing the following button for this specific patient (Please press the link below). If this does not work please contact us immediately and we will help you.
Voorbeeld van validatie patient eCRF

·         What is the difference between the forms D0 and D1 in the Daily Reports Section of the eCRF? After randomization there are two options: starting the study medication immediately or starting the study medication the next day (within 24 hours).

o       In case of starting immediately: fill in form D1 and leave form D0 blank.

o       In case of starting the next day: fill in the requested parameters of the day of randomization in the form D0 and the parameters of the day of initiating the study medication in the form D1.

·         I forgot my inlog and password to get into the eCRF. It could be that your user account has been locked due to not using it for more than 180 days. Please email us at once (stop-bpd@amc.nl) or phone us. We will unlock your account or provide you with a new username and/or password at once. We are working on an automated button on the eCRF to provide you an automated generated new username or password.

·         I can get into the eCRF, but clicking on the first icon gives me a blank page. Your username and password are correct, but the local internet settings disable you to see the page. Go to "internetoptions", then to tab page "security" and the icon "websites". Click on "add" and confirm that this page is a trusted webpage.