2.3. Study Outcome and Sample Collection
infectious or, reflux, digestive intolerance symptoms, weight gain, allergic diseases
ADVERSE EVENTS, REFLUX
The primary outcome of this study was average weight gain of infant between baseline and 4 months. Secondary outcomes were occurrence of adverse events (AEs), anthropometric measurements (recumbent length and head circumference), digestive tolerance, incidence of infectious or allergic diseases, and crying and/or fussing time (hours/day) and episodes.During the study period, infant growth parameters were investigated and recorded at 1, 2, and 4 months. At each visit, the research team reviewed the infant’s daily record of the volume of formula intake/breastfeeding minutes, digestive intolerance symptoms (reflux and gas), sleep duration, frequency of crying/irritability occurrences (hours/day), and episodes. Anthropometric measurements (weight, recumbent length, and head circumference) were also recorded. AEs were assessed based on inquires to the caregivers.