Data Collection Forms
The following data collection forms are for use in the study. Please send completed forms back to trial office by post or email them securely to orh-tr.babyoscar@nhs.net
Form 1: Trial Entry; for completion by recruiting sites
- Complete Part A of the form prior to randomisation and then transcribe the data from Part A into the randomisation program.
- Immediately after randomisation directly record the allocated Study Number and Package ID Number given by the randomisation program in Part B of the form.
- Complete the rest of the form and post to the Trial Office within 7 days of birth.
Form 2: Trial Intervention Form; for completion by recruiting sites
- Complete the form 7 days after the baby has completed trial medication
- If the baby is transferred within 3 days of birth please contact the Co-ordinating Centre.
Form 3: ECHO results at 3 weeks; for completion by recruiting sites
- To be completed any time between 18 - 24 days, or sooner if baby is being transferred to a continuing care site.
Form 4: 36 weeks; for completion at any site, at this time point
- To be completed at 36 weeks PMA or at discharge if discharged home earlier. If a baby is discharged home please ensure that you complete a Form 6: Baby Outcomes.
Form 5: Open Label Treatment of a PDA (after receiving trial medication); for completion by any site should this event occur
- 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
- To be completed when the baby leaves your hospital either to be transferred to another hospital or discharged home, or at death.
Form 6a: NEC Form; for completion by any site should this event occur
This form must be completed along with Form 6: Baby Outcomes for all instances where the baby:
- has definitive Bell stage II or III NEC
- has been transferred with NEC
- died from NEC
If multiple episodes, complete a form for each episode.
Form 7: Baby Withdrawal
Form 8: Serious Adverse Events (SAE); for completion by any site should this event occur
- 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.
