2.3. Follow-Up Evaluation and Compliance
CoMiSS, allergy, CMPA
ADVERSE EVENTS, ALLERGY
Infants were followed-up bimonthly (2nd, 4th, and 6th month) at the study centers during the first six months of life and additional follow-up was performed at any time point if required (development of any signs of allergy or adverse events). At visits, infants were clinically examined and a questionnaire assessing the presence of CMPA and AD signs or symptoms was applied. The SCORAD and CoMiSS tools were additionally completed. Anthropometric measurements were performed by two well-trained research team members in each center. The calibrated scales SECA 354 with a ±20 g precision below 20 kg were used for assessing body weight, while for body length and head circumference, the infantometer SECA 210 and the non-elastic measuring tapes SECA 211 were used, respectively, measuring to the nearest 0.1 cm. All measurements were performed in triplicates and averaged. In cases where two out of three measurements were different by >100 g for weight, >0.7 cm for length, and >0.5 cm for head circumference, a fourth measurement was performed, and the three nearest measurements were averaged.Infants allocated to the study formulas had not consumed any other formula (except extensively hydrolyzed formula) from birth. Solid food introduction was allowed after the age of 4 months and no guidance was given regarding the order of introduction. Formula intake was evaluated using a 7-day milk diary completed during the week preceding the 1st, 2nd, 4th, and 6th month of age. Formula consumption of ≥60 mL/kg body weight/day in the 2nd month (and thereafter), was required to assure a formula intake of about 40% of total daily milk intake. The amount of consumed breastmilk in the mixed-feeding groups was estimated using the equation ‘breastmilk (ml) per kg body weight (BW) = (−2.24 × [infant age in weeks) + 164) − (actual intake of formula/kg BW) [