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. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2
Patient identifiers for analysis inclusion
1. Unique patient ID (anonymous ‐ or please give a new SCiPAD ID and keep log of the corresponding trial ID)
2. Randomised treatment allocation
3. Date of randomisation
4. Received randomised treatment (yes/no)
5. Included in the trials' primary analysis (yes/no)
Primary outcomes
6. Eczema (at all time points collected and using all recorded measures of eczema or eczema symptoms, e.g. UK Working Party definition and investigator‐assessed – please send all eczema measures used and additional variables on skin condition (itch etc) pre formal eczema diagnosis and time point)
7. Food allergy (at all time points collected and using all recorded measures, e.g. using oral food challenge and investigator‐assessed – please send all food allergy measures used)
Secondary outcomes
8. Slippage accidents around the time of bathing or application of emollienta
9. Skin infections during the intervention perioda
10. Stinging or allergic reactions to moisturisersa
11. Serious adverse eventsa
12. Time of eczema onset (first report of a diagnosis of eczema as a specific date or first visit date eczema recorded)
13. Eczema severity ‐ clinician‐assessed: EASI or similar validated measure (at all time points collected)
14. Eczema severity ‐ parent‐assessed: POEM or similar validated measure (at all time points collected)
15. Parent‐reported of immediate (< 2 hours) reaction to a known food allergen: milk, soya, wheat, fish, seafood, peanut, tree nut, egg, or local common food allergen (at all time points collected and for each food allergen recorded)
16. Allergic sensitisation to foods and inhalants via skin prick test (at all time points collected and for each food and inhalant recorded)
Infant baseline characteristics
17. Gestational age at birth
18. Sexb
19. Birth weight
20. Pre‐existing health state in the infant, such as very preterm birth (less than 32 weeks' gestation) or congenital skin condition
21. Infant already diagnosed with eczema at the time of randomisation
22. Infant already diagnosed with food allergy at the time of randomisation
23. Age intervention began (e.g. number of days between birth and randomisation)
24. FLG genotype (method of analysis and what FLG mutations were genotyped)
25. Ethnicity
26. Mode of delivery (e.g. caesarean, vaginal)
27. Method of feeding (e.g. breastfeeding at all time points recorded)
28. Any additional trial randomisation stratification factors
Family baseline characteristics
29. Age of mother at randomisation or enrolment
30. Age of father at randomisation or enrolment
31. Ethnicity of mother
32. Ethnicity of father
33. Educational status of mother
34. Educational status of father
35. Socioeconomic group
36. Singleton or multiple pregnancy
37. Number of other children living at home (without new child – or indicate if this includes the new child)
38. Whether any cats living in the household/living environment?
39. Whether any dogs living in the household/living environment?
40. Mother took any antibiotics during pregnancy?
41. Mother took any regular probiotic supplements during pregnancy?
42. Smoking status of mother
43. Smoking status of father
Family history of atopic disease
44. Number of first‐degree relatives with atopic disease (0, 1, 2, or more)b [Please indicate how atopic disease is defined]
45. Number of first‐degree relatives with eczema (0, 1, 2, or more)
46. Number of first‐degree relatives with food allergy (0, 1, 2, or more)
47. Number of first‐degree relatives with asthma (0, 1, 2, or more)
48. Number of first‐degree relatives with rhinitis/hay fever (0, 1, 2, or more)
Compliance data
49. Data on compliance with intervention, including measures such as grams per day and total number of grams of product dispensed over the study
50. Duration of treatment
51. Dates of treatment withdrawal and reason(s) for treatment withdrawal
Non‐assigned skin care
52. Frequency of bathing
53. Product used for bathing (if not part of intervention)
54. Prescribed topical treatment use
55. Any other skin treatments
For cluster‐randomised trials
56. Cluster‐randomisation factors
Food introduction
57. Any data on the time/age when allergenic foods were introduced
58. Any data on the time/age when solid foods were introduced
EASI: Eczema Area and Severity Index; FLG: filaggrin gene; POEM: Patient‐Oriented Eczema Measure