Open label treatment (both medical and surgical) is permitted within the protocol if the minimum criteria are met and other medical management strategies have been tried
Surgical treatment however should only be considered if the PDA remains persistently large after one course of treatment with a COX inhibitor or in circumstances where medical treatment may be contraindicated or time does not permit medical open label treatment first.
Form 6: Baby Outcomes (Baby Transfer, Discharge or Death); for completion by any site
Unforeseeable SAEs should be reported within 24 hours of first knowledge of the event
Complete and FAX Form 8 to the Baby-OSCAR Trial Co-ordinating Centre on 01865 289 740
Ensure the Baby-OSCAR Trial Co-ordinating Centre is aware of the SAE and check they have received the form
Copy the completed Form 8, send original to the Trial Co-ordinating Centre & place the copy in the baby’s clinical notes
Ensure appropriate follow up of the baby until the event is resolved
If a study physician is not available to make the causality assessment send in the SAE Reporting Form without this information and re-send the form as soon as this assessment has been made.
A Physician who is not a member of the study team may offer an opinion as to whether the event was related to the study drug(s) and this opinion should be documented in the participant’s medical records.