Trial phase Recruitment Randomisation/birth Discharge 7 days post randomisation 3 months 6 months 9 months 12 months End Part 1 18 months 24 months 30 months 36 months 42 months 48 months 54 months 60 months End Part 2
Year data collected 2013-2016 2013-2016 2013-2016 2013-2016 2013-2016 2014-2017 2014-2017 2014-2018 2015-2018 2015-2018 2016-2019 2016-2019 2017-2020 2017-2020 2018-2021 2018-2021
Eligibility X BM C X BM C X C
Withdrawal details X X
Allergy outcomes – eczema diagnosis P:ISAAC P:ISAAC P:ISAAC P:ISAAC
O:SCORAD
P:ISAAC P:ISAAC
O:SCORAD
P:ISAAC P:ISAAC
O:SCORAD
P:ISAAC P:ISAAC P:ISAAC P:ISAAC
O:SCORAD
Allergy outcomes – eczema severity
(including medication use)
P:BIS
P:POEM
P:BIS
P:POEM
P:BIS
P:POEM
P:BIS
P:POEM
O:SCORAD
P:BIS
P:POEM
P:BIS
P:POEM
O:SCORAD
P:BIS
P:POEM
P:BIS
P:POEM
O:SCORAD
P:BIS
P:POEM
P:BIS
P:POEM
P:BIS
P:POEM
P:BIS
P:POEM
O:SCORAD
Allergy outcomes – wheezing
(bronchodilator use, oral and inhaled
steroid use, severity)
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
P:HN
P:ISAAC
Allergy outcomes – food allergy
(doctor diagnosed, epipen prescription/use,
doctor diagnosed reflux, skin prick test,
oral food challenge) 1
P:SDV P:SDV P:SDV P:SDV
O:SPT
O:OFC (if positive SPT)
P:SDV P:SDV P:SDV P:SDV P:SDV P:SDV P:SDV P:SDV
O:SPT
O:OFC (if positive SPT)
Immunisation status 2 M BM
P:SDV BM
M C P:SDV Si P:SDV Si P:SDV Si P:SDV C Si
M C
P:SDV Si P:SDV Si
M C
P:SDV Si P:SDV Si
M C
P:SDV Si P:SDV Si P:SDV Si P:SDV C Si
M C
Response to BCG vaccination
(antibody response (blood test))
X X X X X X
Response to BCG vaccination
(photo of scar/scar size)
P:SDV 3
O:SDV 3
P:SDV P:SDV P:SDV P:SDV
O:SDV
P:SDV
O:SDV
P:SDV
O:SDV
P:SDV P:SDV
O:SDV
P:SDV P:SDV P:SDV P:SDV
O:SDV
Adverse events
(normal/concern, local, regional,
distant, disseminated, underlying diagnosis)
P:SDV C
O
P:SDV C
O
P:SDV C
O
P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C P:SDV C

Featured measurements

BIS: Barwon Infant Study derived
HN: HealthNuts Study derived
ISAAC: International Study of Asthma and Allergy in Children adaptation
OFC: Oral Food Challenge (HealthNuts protocol)
POEM: Patient-Oriented Eczema Measure
SCORAD: SCORing Atopic Dermatitis
SDV: Study Devised Variable
SPT: Skin Prick Test (HealthNuts protocol)

Notes

1 SPT and OFC protocols based on BIS and HealthNuts protocols
2 Maternal Hep B, BCG, flu and pertussis vaccination status obtained at recruitment, neonatal Hep B vaccination status (and intervention BCG status) obtained at discharge, full vaccination status of index child obtained at 1-year and 5-year visits and/or from ACIR (Australian Childhood Immunisation Register)
3 Photo at 7 days post randomisation was optional (too early for side effects to appear)

Legend

A = Administration report abstraction
C = Index child report (reporting on others)
L = Linkage (to other databases)
M = Medical records data abstraction
O = Observation/direct assessment
N = Nurse report
P = Parent/primary caregiver report
Pe = Peer report
S = Self report
T = Teacher report
X = Undefined
X BF = Pertaining to biological father
X BM = Pertaining to biological mother
C = Pertaining to index child
X F = Pertaining to father
X Fam = Pertaining to family
X G = Pertaining to grandparent(s)
X M = Pertaining to mother
X P = Pertaining to parent(s)
X Pa = Pertaining to partner
X Pe = Pertaining to peers
X Pr = Pertaining to primary caregiver
X Si = Pertaining to sibling(s)