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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.
Insights
A partially hydrolyzed cow milk protein (PHP) formula with prebiotics did not reduce infant fussiness compared to standard formula. However, it did significantly decrease crying and instances of excessive crying in fussy infants.
Area of Science:
- Pediatrics
- Infant Nutrition
- Gastroenterology
Background:
- Infant fussiness and crying are common parental concerns.
- Formula changes are often considered for formula-fed infants experiencing fussiness.
Purpose of the Study:
- To evaluate a partially hydrolyzed cow milk protein (PHP) formula with prebiotics for perceived infant fussiness.
- To assess effects on infant comfort measures including crying and gassiness.
Main Methods:
- A randomized controlled trial involving 149 infants (15-75 days old) with moderate to extreme fussiness.
- Infants received either intact cow milk protein formula (control) or investigational PHP formula with prebiotics for 28 days.
- Parent-reported outcomes were analyzed using repeated-measures analysis of variance.
Main Results:
- No significant difference in parent-reported fussiness between the PHP formula and control groups.
- Significant reductions in crying duration (P=0.01) and excessive crying (P≤0.045) were observed with the PHP formula.
- Within-group analysis showed significant decreases in fussiness, gassiness, and spit-up from baseline to day 1 and sustained through study end.
Conclusions:
- Partially hydrolyzed cow milk protein formula with prebiotics did not decrease fussiness compared to control formula in fussy infants.
- The investigational formula was associated with reduced crying and excessive crying.
- Adverse events were low and similar between groups.
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.
