Nentwich 2001.

Methods	Single‐centre quasi‐randomised (alternation) controlled trial in Czech Republic.
Participants	Inclusion criteria: pregnant women who themselves, husbands or children attended an allergic disease or dermatology outpatient clinic (i.e. family history of atopy in first‐degree relative).
Interventions	Mothers encouraged to breast feed for at least 6 months to avoid cow's milk and highly allergenic foods. Allocated sole or supplemental formula if unable to solely breast feed according to prenatal treatment allocation. Treatment 1 (n = 37): partially hydrolysed whey CMF (Beba HA, Nestle, Denmark). Treatment 2 (n = 35): extensively hydrolysed whey CMF (Hipp HA, Hipp GnbH, Gmunden, Austria). Co‐interventions: all mothers encouraged to breast feed for 6 months, avoid cow's milk for first 6 months, introduce solids after 6 months and delay allergenic foods to after 12 months. At 6 months: 24/37 fed PHF and 21/35 fed EHF. At 12 months: 31/37 fed PHF and 28/35 EHF.
Outcomes	Primary outcome(s): antigen‐specific reactivity of mononuclear cells to cow's milk protein; cow's milk‐specific IgE and IgG; atopic skin symptoms. Other outcomes: symptom diaries kept. Blinded paediatrician assessment for atopic dermatitis. Reported weights up to 12 months (data not given). Definitions Atopic dermatitis: typical rash in at least 2 locations relapsing for at least 3 months' duration. Standardised score used (SCORAD). Allergic disease reported at 6 and 12 months (infant allergic disease).
Notes	Trial of sole or supplemental feeding pHWF vs extensively hydrolysed whey formula in high‐risk infants unable to be completely breast fed in first 6 months. Conflict of interest: supported by research grants. The "study done independently of infant food companies".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quasi‐random ‐ prenatal randomisation by odd and even numbers.
Allocation concealment (selection bias)	High risk	Prenatal randomisation by odd and even numbers. Postnatal allocation to formula if unable to fully breast feed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Paediatrician prescribing treatment aware of allocation. Formula not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Second paediatrician unaware of allocation.
Incomplete outcome data (attrition bias) All outcomes	High risk	1/73 (1%) post randomisation loss. 13/72 (18%) not fed HF and reported in separate group.
Selective reporting (reporting bias)	Low risk	Prespecified atopic skin symptoms in first 12 months of life. Standardised definitions.
Other bias	High risk	Groups appeared well balanced after allocation. However, not intention‐to‐treat analysis.