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.
RCT Entities:
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.