Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial
Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial
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DOI：
10.1001/jamapediatrics.2019.1424
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发表时间：
2019-08-01
期刊：
影响因子：
26.1
通讯作者：
Paul, Ian M.
中科院分区：
文献类型：
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作者：
Flaherman, Valerie J.;Cabana, Michael D.;Paul, Ian M.
关键点为高危足月新生儿提供结构化的短期配方奶粉补充是否会影响6个月和12个月时仍在母乳喂养的比例？在这项随机临床试验中，纳入了164对新生儿体重减轻达到或超过75百分位数的母亲-新生儿，结构化的短期新生儿配方奶粉补充剂不会影响6个月时的母乳喂养率。以结构化的短期方式使用新生儿配方奶粉补充剂对6个月内的母乳喂养没有影响;需要进一步的研究来确定它对母乳喂养的影响，通过推荐的12个月的持续时间。在出生后的第一周内，对新生儿进行纯母乳喂养或补充少量配方奶粉的母乳喂养，以评估配方奶粉补充对重要性6个月和12个月的母乳喂养是疾病控制和预防中心2020年健康人群倡议的2个目标，但只有52%的美国婴儿达到了6个月的目标，30%的美国婴儿达到了12个月的目标。目的确定高危新生儿结构化短期配方奶粉补充是否影响6个月和12个月时仍母乳喂养的比例。设计，设置，和婴儿这一随机临床试验在2个美国学术医学中心进行，招募了164个纯母乳喂养的母亲，婴儿谁还没有产生大量的牛奶和婴儿谁是24至72小时的新生儿体重减轻或以上的第75百分位数的年龄。参与者于2015年1月至2016年9月入组。干预早期有限配方奶粉（ELF），一种结构化的配方奶粉补充方案（每次母乳喂养后喂养10 mL配方奶粉，直到母亲产生大量的牛奶），与对照组相比，他们继续纯母乳喂养并接受安全教育干预。主要结果和测量研究的主要结果是6个月时的任何母乳喂养。次要结果包括停止母乳喂养时的年龄和12个月时的任何母乳喂养。所有结果均通过母亲电话调查进行评估。结果82例新生儿随机分为ELF组和对照组。平均（SD）母亲年龄为31.4（5.9）岁，114（69.5%）例自我认定为非西班牙裔白色; 20（12.2%）例为西班牙裔; 17（10.4%）例为亚裔; 5（3.0%）例为非西班牙裔黑人; 7（4.3%）例为其他。与对照组相比，随机分配至ELF组的母亲结婚的可能性较低（n=53 [64.6%] vs n=66 [80.5%]; P= 0.03），预期母乳喂养的平均（SD）持续时间较短（8.6 [3.4] vs 9.9 [4.4]个月; P= 0.049）。队列中母乳喂养的中位（四分位距）持续时间为9（6-12）个月。6个月时，47名（65%）随机分配至ELF组的婴儿母乳喂养，而对照组婴儿为60名（77%）（绝对差异，-12%; 95%CI，-26%至3%; P= 0.12）。在12个月时，71名ELF婴儿中有21名（29.6%）可用于分析，而77名对照婴儿中有37名（48.1%）为母乳喂养（风险差异，-18%; 95%CI，-34%至-3%）。婚姻状况和预期母乳喂养持续时间均与母乳喂养持续时间相关;调整这些因素的模型发现，与对照组婴儿相比，ELF婴儿在12个月内停止母乳喂养的风险比为0.74（95%CI，0.48-1.14）。结论和相关性在这个母乳喂养率高的队列中，ELF与母乳喂养持续时间的任何改善无关。未来的研究应该检查ELF在早期戒烟风险较高的人群中的作用。试用版RegistrationClinicalTrials.gov标识符：NCT 02313181
Key PointsQuestionDoes structured, short-term formula supplementation for at-risk term neonates affect the proportion still breastfeeding at 6 and 12 months? FindingsIn this randomized clinical trial that enrolled 164 mother-newborn dyads with newborn weight loss at or above the 75th percentile for hour of age, structured, short-term neonatal formula supplementation did not affect breastfeeding prevalence at 6 months. MeaningUsing neonatal formula supplementation in a structured, short-term manner did not affect breastfeeding through 6 months; further research is needed to determine its effect on breastfeeding through the recommended duration of 12 months.This randomized clinical trial assigns mother-newborn dyads to exclusive breastfeeding or breastfeeding supplemented with small amounts formula in the first week of life to evaluate the effect of formula supplementation on duration of breastfeeding at 6 and 12 months.ImportanceBreastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. ObjectiveTo determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months. Design, Setting, and ParticipantsThis randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016. InterventionsEarly Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention. Main Outcomes and MeasuresThe study's primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey. ResultsEighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n=53 [64.6%] vs n=66 [80.5%]; P=.03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P=.049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, -12%; 95% CI, -26% to 3%; P=.12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, -18%; 95% CI, -34% to -3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group. Conclusions and RelevanceIn this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation. Trial RegistrationClinicalTrials.gov identifier: NCT02313181