Randomized trial of early infant formula introduction to prevent cow's milk allergy.,Journal of Allergy and Clinical Immunology

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Randomized trial of early infant formula introduction to prevent cow's milk allergy.
Journal of Allergy and Clinical Immunology ( IF 11.4 ) Pub Date : 2020-09-02 , DOI: 10.1016/j.jaci.2020.08.021
Tetsuhiro Sakihara ₁ , Kenta Otsuji ₂ , Yohei Arakaki ₃ , Kazuya Hamada ₄ , Shiro Sugiura ₅ , Komei Ito ₅

Affiliation

Background

Previous research has produced conflicting evidence on the preventive effects of early introduction of cow’s milk protein on cow’s milk allergy (CMA).

Objective

Through a randomized controlled trial, we sought to determine whether the early introduction of cow’s milk formula (CMF) could serve as an effective strategy in the primary prevention of CMA in a general population.

Methods

We recruited newborns from 4 hospitals in Okinawa, Japan. Participants were randomly allocated to ingest at least10 mL of CMF daily (ingestion group) or avoid CMF (avoidance group) between 1 and 2 months of age. In the avoidance group breast-feeding was supplemented with soy formula as needed. Oral food challenge was performed at 6 months of age to assess CMA development. Continuous breast-feeding was recommended for both groups until 6 months of age.

Results

We identified 504 infants for randomization into the 2 groups. In all, the parents of 12 participants declined to receive the intervention, and the study sample comprised 491 participants (242 in the ingestion group and 249 in the avoidance group) for a modified intention-to-treat analysis. There were 2 CMA cases (0.8%) among the 242 members of the ingestion group and 17 CMA cases (6.8%) among the 249 participants in the avoidance group (risk ratio = 0.12; 95% CI = 0.01-0.50; P < .001). The risk difference was 6.0% (95% CI = 2.7-9.3). Approximately 70% of the participants in both groups were still being breast-fed at 6 months of age.

Conclusions

Daily ingestion of CMF between 1 and 2 months of age prevents CMA development. This strategy does not compete with breast-feeding.

中文翻译：

早期婴儿配方奶粉引入预防牛奶过敏的随机试验。

背景

先前的研究已经就早期引入牛奶蛋白对牛奶过敏 (CMA) 的预防作用产生了相互矛盾的证据。

客观的

通过一项随机对照试验，我们试图确定早期引入牛奶配方 (CMF) 是否可以作为普通人群 CMA 一级预防的有效策略。

方法

我们从日本冲绳的 4 家医院招募了新生儿。参与者被随机分配到每天至少摄入 10 mL CMF（摄入组）或在 1 至 2 个月大时避免 CMF（避免组）。在回避组中，母乳喂养根据需要补充大豆配方。在 6 个月大时进行口服食物挑战以评估 CMA 的发展。两组均建议持续母乳喂养至 6 个月大。

结果

我们将 504 名婴儿随机分为两组。总共有 12 名参与者的父母拒绝接受干预，研究样本包括 491 名参与者（摄入组 242 人，避免组 249 人），用于改良的意向治疗分析。摄入组的 242 名成员中有 2 例 CMA 病例（0.8%），回避组的 249 名参与者中有 17 例 CMA 病例（6.8%）（风险比 = 0.12；95% CI = 0.01-0.50；P < . 001）。风险差异为 6.0%（95% CI = 2.7-9.3）。两组中大约 70% 的参与者在 6 个月大时仍在母乳喂养。