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A Randomized Controlled Trial of a Partially Hydrolyzed Formula on Comfort Measures in Fussy Infants
Veronica Fabrizio1,2, Michelle M Bohan Brown3, Philip Boucher4
1Evidence Generation and Clinical Research, Mead Johnson Nutrition, Evansville, IN.
Background:
Parent-reported fussiness and crying are common during early infancy and may be alleviated by switching the formula for infants who are formula fed.
Objectives:
This study evaluated the nutritive effects of a partially hydrolyzed cow milk protein (PHP) formula with an added prebiotic blend on parent/caregiver-reported fussiness and other measures of comfort in infants with perceived fussiness.
Methods:
Infants (15-75 d of age) exclusively receiving a commercial intact protein infant formula and rated moderately, very, or extremely fussy were randomized to receive intact cow milk protein formula (control, n = 73) or investigational PHP formula (INV-PHP, n = 76). Both formulas had a prebiotic blend of polydextrose and galactooligosaccharides (1:1, 4 g/L). Parent-reported outcomes at baseline (D0), end of study feeding day 1 (D1), and daily over the 28-d study feeding were analyzed using repeated-measures analysis of variance.
Results:
Of 149 infants randomly assigned, 127 completed study feeding (control, n = 65; INV-PHP, n = 62). The primary outcome of parent-reported fussiness was not different between groups. Among secondary outcomes between the groups, there was a significant decrease in crying throughout the study (weeks 1-4; P = 0.01) and significantly fewer infants who experienced excessive crying during the study (weeks 1, 2, and 4; P ≤ 0.045). Formula intake was not different between groups. Incidences of adverse events were low with no significant group differences. On post hoc analysis, within each group, fussiness, gassiness, and spit-up significantly decreased from D0 to D1 (P < 0.001) and was maintained through study end (P < 0.001).
Conclusion:
In infants with parent-perceived fussiness, a partially hydrolyzed cow milk protein formula with an added prebiotic blend, INV-PHP, does not decrease fussiness when compared with control formula but does reduce crying and excessive crying.The study was registered at clinicaltrials.gov as NCT05245422.
