Study setting and PAL development
Allergy, rash, Infection
SKIN CONDITION, ALLERGY, INFECTION
In the MIS BAIR trial, 8552 participants were assessed for eligibility with 7280 excluded and 1272 healthy neonates randomised to receive BCG-Denmark vaccine or no vaccine within 10 days of birth (CONSORT diagram for MIS BAIR PAL study.MIS BAIR, Melbourne Infant Study: BCG for Allergy and Infection Reduction; PAL, paediatric advice line.The PAL involved a single contact number linked to a mobile phone carried by a clinical staff member during standard business hours (0900–1700 on weekdays). Parents were told that it was intended only for non-urgent medical questions and a voicemail could be left by callers outside of standard business hours with a return call within one business day. A clinical member of the study team (doctor, nurse or midwife with paediatric experience) responded to all calls and provided advice (sometimes with emailed resources). The PAL comprised 15 clinicians rostered to hold the PAL mobile device on a voluntary rotating roster for the duration of one day. If a nurse or midwife receiving PAL calls on a particular day required medical input, a referral was completed to a medical MIS BAIR staff member with a return call within one business day. Parents calling for a rash or skin condition were asked to send photographs by email or smartphone. If appropriate, follow-up calls were arranged with a nurse, a paediatrician, the participant’s general practitioner, a specialist clinic or at the emergency department.