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1: Recruitment

2: Provision of Study Medicine

3: Follow Up Procedures

4: Active Surveillance for SAESI

5: Participant withdrawal

6: Using an Interpreting Service

7: Contact Points

CMDHB Procedures


  1. Sticker in baby book
  2. Load drug browser link on participant's phone 
  3. Discuss use of allocated drug at immunisation

Portal Alerts

  1. Use PIMS alert system
  2. Email patient services to remove National Alerts if participant withdraws from study and is in the ibuprofen group

Alerts on ADHB enrolled participants

  1. Place PIMS alerts on ADHB enrolled participants only if admitted for acute care to CMDHB.

GP / Concerto Letters

  1. Letters are generated via Soprano with patient details populated from PIMS. Use the REDCap GP letter to confirm drug allocation and to cut and paste names of siblings. 
  2. The baby's GP defaults to the mother's. If the mother intends to take her baby to another GP, update the baby’s demographic via the ward clerk before creating the GP letter. 
  3. If the baby has a new GP at 1 month, post the REDCap generated letter to the new GP. 
  4. If the baby is known to have cross-over due to GP prescribing, send GP deviation letter via Soprano. 

Recording of medication exposure in hospital

  1. Monitor participant admissions via ED
  2. Research team to collect medication administration data and enter into REDcap under closest epoch. 
  3. Record paracetamol & ibuprofen usage only.
  4. Do a new eCRF for each admission. 


  1. If cross-over is due to GP prescribing see above for GP letters
  2. If noted in epoch send reminder email with study objectives


  1. Home visit if no response after 10 days.


  1. Ensure that dose does not exceed 400 mg for ibuprofen and 1000 mg for paracetamol.

    Decision Trees

  2. Cancelling Prescriptions
    1. leave the answer blank to ‘Route of prescription to participant’ question
    2. scroll down the bottom and tick the ‘Cancel prescription’ checkbox

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