针对有家长报告配方奶不耐受迹象的婴儿对两种配方奶的临床反应：一项多国、双盲、随机试验

Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.

作者信息

Vivatvakin Boosba, Estorninos Elvira, Lien Reyin, Lee Hung Chang, Hon Kam Lun Ellis, Lebumfacil Jowena, Cercamondi Colin I, Volger Sheri

机构信息

Chulalongkorn University, Bangkok, Thailand.

Asian Hospital and Medical Center, Muntinlupa City, Philippines.

出版信息

Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.

DOI:10.1177/2333794X20954332

PMID:33029552

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7522826/

Abstract

BACKGROUND

Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high -2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance.

METHODS

In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days. Primary endpoint was daily duration of fussiness-crying. Secondary endpoints included gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety.

RESULTS

Mean ± SE minutes/day of fussiness-crying in the 256 analyzed infants (FA, n = 127 and FB, n = 129) substantially decreased from baseline to study end in FA (291 ± 14 to 140 ± 8; -52%, < .001), and FB (313 ± 14 to 153 ± 11, -51%, < .001) with no difference between groups. Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas. Mean ± SE IGSQ index scores significantly decreased from baseline to study end (FA: 44.5 ± 0.9 to 28.6 ± 0.7; FB: 44.5 ± 0.8 to 29.0 ± 0.7; < .001) with no differences between groups. Infant temperament and maternal anxiety also improved significantly in both groups by study end.

CONCLUSION

Switching from standard, full-lactose, intact whey/casein infant formulas to either study formula resulted in an improvement of gastrointestinal symptoms and associated behaviors in infants with signs of feeding intolerance.

TRIAL REGISTRATION

https://clinicaltrials.gov, NCT02021058.

摘要

背景

喂养不耐受的体征在配方奶喂养的婴儿中很常见。我们评估了健康足月儿在出现家长报告的喂养不耐受体征时，对一种高 -2 棕榈酸酯且乳糖含量降低的部分水解 100% 乳清蛋白配方奶粉（FA）和一种富含 α-乳白蛋白且以乳清为主的全乳糖完整蛋白配方奶粉（FB）的临床反应。

方法

在 6 个亚洲研究中心进行的一项双盲、平行组试验中，将年龄在 30 至 90 天、完全以配方奶喂养、家长报告每天烦躁哭闹≥2 小时且伴有肠胃胀气和/或排便困难且打算更换配方奶粉的婴儿随机分为 FA 组（n = 130）或 FB 组（n = 129），为期 14 天。主要终点是每日烦躁哭闹的时长。次要终点包括肠胃胀气、吐奶、呕吐、睡眠模式、婴儿胃肠道症状问卷（IGSQ）指数、婴儿气质和母亲焦虑。

结果

在 256 名分析的婴儿（FA 组，n = 127；FB 组，n = 129）中，从基线到研究结束时，FA 组每日烦躁哭闹的平均分钟数（均数±标准误）大幅下降（从 291±14 降至 140±8；-52%，P <.001），FB 组也有类似下降（从 313±14 降至 153±11，-51%，P <.001），两组间无差异。同样，到研究结束时，两种配方奶粉的肠胃胀气、吐奶、呕吐和睡眠模式均有显著改善。从基线到研究结束时，IGSQ 指数的平均（均数±标准误）得分显著下降（FA 组：44.5±0.9 降至 28.6±0.7；FB 组：44.5±0.8 降至 29.0±0.7；P <.001），两组间无差异。到研究结束时，两组婴儿的气质和母亲焦虑也有显著改善。