Stress medication procedure

 

The SToP-BPD study will allow for a preventive stress dose treatment if this is deemed necessary according to the local protocol of the participating NICU. Patients will receive a stress dose identical to their study medication. The prescribed stress dosing schedule is 5 mg/kg Q.I.D. (four times a day) on the day the event occurs, subsequently lowering the frequency by one dose every day.

 

Schedule:

Day of event: 5 mg/kg Q.I.D. (four times a day)

Day 2: 3.75 mg/kg T.I.D. (three times a day)

Day 3: 2.5 mg/kg B.I.D. (two times a day)

Day 4: 1.25 mg/kg O.P.D. (once a day)

 

Note: preventive treatment with a stress dose is NOT mandatory.

Note 2: If a patient shows signs of adrenal insufficiency at any time during a stressful event, he or she should be treated with open label hydrocortisone according to the dosing schedule mentioned in this paragraph.

 

To allow a stress dose identical to the study medication, every site of the study will have four extra “stress-kits” with a unique identification number, containing 11 vials of the study medication. Please read the possible scenarios during the study to determine whether you need such a stress-kit.

 

Three scenarios are possible during the study:

  1. The patient experiences a stress episode (i.e. surgery or sepsis) during the administration of the study medication till the 18th day after randomization. No new kit will be necessary because the “regular” medication kit will be sufficient to administer a stress dose. To view the procedure click here.
  2. The patient experiences a stress episode (i.e. surgery or sepsis) on the 19th till the 22nd day of study medication. In this case, the possibility exists that there are not enough vials for the stress schedule. The procedure to obtain the number of the stress kit click here.
  3. The patient experiences a stress episode (i.e. surgery or sepsis) after the administration of the study medication (>22 days after randomization). In this case a new stress kit will be necessary. The procedure to obtain the number of the stress kit click here.