| Methods |
Single‐centre randomised controlled trial in Taiwan. |
| Participants |
Inclusion criteria: healthy term infants. Family history of allergic disease score used. Infants with score > 3 enrolled. |
| Interventions |
Treatment (n = 15): infants breast fed for 1 to 2 months, then fed PHF for subsequent 4 months (Nan HA, Nestle). All except 2 infants received formula.
Control (n = 18): regular formula from birth.
No co‐interventions reported. |
| Outcomes |
Primary outcome(s): allergic diseases.
Other outcomes: seen at 1, 2, 4, 6, 12 months (infant allergic disease incidence) in well baby clinic. Total and specific IgE at 2, 6, 12 months. SPTs in cases of suspected allergic disease. Growth in weight and height up to 12 months.
Definitions
Atopic dermatitis: grading score used (mild: faint lesions on forehead or cheek without treatment; moderate and severe: lesions required treatment).
Allergic rhinitis: typical symptoms in early morning.
Wheezing: any. |
| Notes |
Trial of prolonged supplementary or sole pHWF vs CMF.
Data not reported in group of allocation for clinical allergic disease confirmed by skin prick testing, and possibly for growth.
Conflict of interest: financial support and formula provided by ANPING Ltd. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Qquote: "The newborns were randomly allocated to two groups". Method not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Method not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Unlikely. Infants fed CMF from birth. Those fed PHF breast fed for 1 to 2 months. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Cross‐over of 3 infants from hydrolysed to CMF group (unclear which reported outcomes this affected). |
| Selective reporting (reporting bias) |
Unclear risk |
Did not report prespecified definition of specific allergic disease or time of reporting. |
| Other bias |
Low risk |
No reported differences between study groups for cord blood IgE, family history allergic disease score or duration of follow‐up. |
