, et al
Lactose-free milk or soy-based formulas do not improve caregivers’ distress or perceptions of difficult infant behavior
J Pediatr Gastroenterol Nutr

Investigators from Vanderbilt University and Mead Johnson Nutrition conducted a double-blind randomized controlled trial to determine whether changing from regular, lactose-containing formula to either lactose-free (LF) milk-based or LF soy-based formula improved behavior in young infants with perceived feeding intolerance. Infants between 2 and 12 weeks of age were eligible for inclusion if their caregivers reported as a primary concern commonly perceived feeding problems (fussiness, crying, cramping, gas, or diarrhea) in the past week at a visit to a participating pediatrician’s office. Only infants who had been exclusively fed a milk-based formula for at least 5 days were enrolled in the study. Enrolled infants were randomized to receive 1 of 3 formulas: LF milk-based, LF soy-based, or milk-based lactose-containing formula (control). Assigned formulas were exclusively consumed for 14 days. Caregivers completed pre- and post-study validated questionnaires regarding infants’ difficult behaviors such as fussiness and irritability (Infant Characteristics Questionnaire), caregivers’ distress (The Maternal Efficacy Questionnaire), and satisfaction with the assigned formula. Changes in scores on these questionnaires from baseline to post-study were compared among infants and their female caregivers in the 3 formula groups.

A total of 291 dyads of infants and female caregivers were enrolled; 234 completed the study, including 85 randomized to the control formula, 80 to LF milk-based, and 69 to LF soy-based. There were no significant differences between any of the 3 formula groups for any of the outcomes (infant behaviors, caregivers’ distress, or satisfaction with the formula). However, during the 14-day study period, difficult infant behaviors and caregivers’ distress significantly improved across all formula groups.

The authors suggest that commonly reported difficulties in some infants’ behaviors in the first months of life are more likely related to infant development than to feeding problems.

A recent CDC survey of breastfeeding in the United States reveals that 77% of newborns initiate breastfeeding and 49% are still breastfeeding by age 6 months, implying that 23% to 51% of infants 0–6 months of age are being fed formula. Formula-fed babies may have firmer stools compared to breastfed infants at the same age. Problems with fussiness, crying, cramping, gas, and diarrhea are commonly reported to occur during the first few weeks of life. Persistent crying and fussy behaviors are reported to occur in 16% of breastfed infants and 43% of formula-fed infants at 2 weeks of age and 31% of breastfed infants and 12% of formula-fed infants at 6 weeks of age. In formula-fed babies, these problems are frequently managed by changing from a cow’s milk-based formula to a soy-based formula because of presumed formula intolerance. As a result, about 25% of mothers conclude that their infant is allergic to cow’s milk, affecting their perceptions about their child’s future health.4...

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