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.
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: