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Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial
P L Lucassen1, W J Assendelft, J W Gubbels
1Institute for Research in Extramural Medicine, Vrije Universiteit, Amsterdam, the Netherlands.
Objective:
To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands.
Study Design:
Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).
Main Outcome Measure:
Difference in duration of crying (minutes per day) between qualification week and intervention week.
Results:
Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.
Conclusions:
An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.