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婴儿腹绞痛:使用乳清水解蛋白减少哭闹时间:一项双盲、随机、安慰剂对照试验

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

作者信息

Lucassen P L, Assendelft W J, Gubbels J W, van Eijk J T, Douwes A C

机构信息

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

出版信息

Pediatrics. 2000 Dec;106(6):1349-54. doi: 10.1542/peds.106.6.1349.

DOI:10.1542/peds.106.6.1349
PMID:11099588
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.

摘要

目的

确定乳清蛋白水解配方奶粉在荷兰初级保健机构中治疗婴儿腹绞痛的有效性。

研究设计

随机、双盲、平行试验,有1周的资格期和1周的干预期。参与者。43名健康、发育良好、以配方奶粉喂养的6个月以下婴儿,每周至少3天每天哭闹超过3小时。婴儿被随机分为乳清蛋白水解配方奶粉组(n = 23)或标准配方奶粉组(n = 20)。

主要观察指标

资格周和干预周之间哭闹持续时间(每天分钟数)的差异。

结果

根据意向性分析原则,分析显示乳清蛋白水解配方奶粉组每天哭闹持续时间减少63分钟[95%置信区间:每天1 - 127分钟]。5名婴儿未完成试验。研究范围不足以期望亚组分析中有显著差异。

结论

在初级保健机构中,深度水解乳清配方奶粉可有效缩短哭闹持续时间。

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Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial.婴儿腹绞痛:使用乳清水解蛋白减少哭闹时间:一项双盲、随机、安慰剂对照试验
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