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 |