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Pediatrics. 2000 Dec;106(6):1349-54.

Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial.

Author information

  • 1Institute for Research in Extramural Medicine, Vrije Universiteit, Amsterdam, the Netherlands.

Abstract

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.

PMID:
11099588
[PubMed - indexed for MEDLINE]
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