| Methods |
Single‐centre randomised controlled trial in Italy. |
| Participants |
Inclusion criteria: infants with at least 1 first‐degree relative with allergic disease. When history in doubt, SPTs or RAST performed. |
| Interventions |
Treatment (n = 23): pHWF (Nidina‐HA, Nestle).
Control (n = 39): CMF (Nidina, Nestle).
Co‐interventions: none reported.
Formula only to 6 months, then 'normal' diet. |
| Outcomes |
Primary outcome(s): allergic disease at 6 and 24 months (infant allergic disease).
Other outcomes: physician clinical examination and/or telephone contact to determine incidence of allergic disease. CMPI, eczema and asthma diagnosed clinically according to standard criteria. |
| Notes |
Trial of sole prolonged pHWF vs CMF.
Conflict of interest: none reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Method not reported. |
| 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. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
None reported. |
| Selective reporting (reporting bias) |
Low risk |
Prespecified allergic disease and timing of reporting. |
| Other bias |
High risk |
Group characteristics not reported. Group sizes unequal. |
