| Methods |
Single‐centre randomised controlled trial in Italy. |
| Participants |
Inclusion criteria: infants of mothers with atopy (rhinitis, asthma, eczema or food intolerance) who "could not breast feed". |
| Interventions |
Treatment (n = 21): partially hydrolysed cow's milk whey formula (Vivena HA‐Primigiorni HA).
Control (n = 14): CMF (brand not reported).
Co‐interventions (in all 'at‐risk infants'): avoidance of passive smoking, exposure to pets and mites, avoidance of nurseries, delayed weaning to 6 months of age. |
| Outcomes |
Primary outcome(s): immunogenicity and antigenicity of pHWF in at‐risk infants, including RAST for milk and egg proteins, total and specific IgE and specific IgG and IgG4 subclass antibodies.
Other outcomes: eczema: defined as a pruritic, chronic or chronically relapsing dermatitis with typical features and distribution.
Follow‐up to 6 months (infant eczema incidence). |
| Notes |
Trial of sole prolonged partially hydrolysed whey CMF and environmental allergen avoidance vs CMF.
Conflict of interest: none reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method of sequence generation not reported. |
| Allocation concealment (selection bias) |
Low risk |
After informed consent was obtained from parents, infants considered at risk of atopy and who could not be breast fed were randomised (by the sealed‐envelope method) to treatment on the first day of life. Only infants who were exclusively breast fed, special formula fed or traditional formula fed and who were not exposed to passive smoking during the first 6 months of life were included in the study. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not reported for clinical outcomes. Reported for measurement of sensitisation (specific IgE). |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Numbers of enrolled infants not reported. Only infants who received 6 months of allocated formula analysed. |
| Selective reporting (reporting bias) |
Unclear risk |
Specific clinical outcomes not reported to be prespecified. |
| Other bias |
High risk |
Unequal numbers in groups reported. |
