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Abstract：
BACKGROUND: Concerns about reduced milk transfer with nipple shield (NS) use are based on evidence from studies with methodological flaws. Milk removal during breastfeeding can be impacted by infant and maternal factors other than NS use. The aim of this study was to control electric breast pump vacuum strength, pattern and duration across multiple study sessions to determine if NS use reduces milk removal from the breast.
METHODS: A within-subject study with two groups of breastfeeding mothers (infants < 6 months) were recruited; Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS for persistent nipple pain. Mothers completed three randomised 15 min pumping sessions using the Symphony vacuum curve (Medela AG); no NS, fitted NS, and a small NS. Sessions were considered valid where the applied vacuum was within 20 mmHg of the set vacuum. Milk removal was considered as pumped milk volume, and also percentage of available milk removed (PAMR), which is calculated as the pumped volume divided by the estimated milk volume stored in the breast immediately prior to pumping.
RESULTS: Of 62 sessions (all: n = 31 paired sessions) a total of 11 paired sessions from both PG (n = 03) and CG (n = 08) were valid (subset) with and without a fitted NS. Only 2 small shield sessions were valid and so all small shield measurements were excluded. Both pumped volumes and PAMR were significantly lower with NS use for all data but not for subset data. (All: Volume and PAMR median: no NS: 76.5 mL, 69%, Fitted NS: 32.1 mL, 41% respectively (volume p = 0.002, PAMR p = 0.002); Subset: Volume and PAMR median: no NS: 83.8 mL, 72%; Fitted NS: 35.2 mL, 40% (volume p = 0.111 and PAMR p = 0.045). The difference in PAMR, but not volume, was statistically significant when analysed by linear mixed modelling. A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
CONCLUSIONS: This experimental data suggests that nipple shield use may reduce milk removal. Close clinical monitoring of breastfeeding mothers using nipple shields is warranted.
METHODS: A within-subject study with two groups of breastfeeding mothers (infants < 6 months) were recruited; Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS for persistent nipple pain. Mothers completed three randomised 15 min pumping sessions using the Symphony vacuum curve (Medela AG); no NS, fitted NS, and a small NS. Sessions were considered valid where the applied vacuum was within 20 mmHg of the set vacuum. Milk removal was considered as pumped milk volume, and also percentage of available milk removed (PAMR), which is calculated as the pumped volume divided by the estimated milk volume stored in the breast immediately prior to pumping.
RESULTS: Of 62 sessions (all: n = 31 paired sessions) a total of 11 paired sessions from both PG (n = 03) and CG (n = 08) were valid (subset) with and without a fitted NS. Only 2 small shield sessions were valid and so all small shield measurements were excluded. Both pumped volumes and PAMR were significantly lower with NS use for all data but not for subset data. (All: Volume and PAMR median: no NS: 76.5 mL, 69%, Fitted NS: 32.1 mL, 41% respectively (volume p = 0.002, PAMR p = 0.002); Subset: Volume and PAMR median: no NS: 83.8 mL, 72%; Fitted NS: 35.2 mL, 40% (volume p = 0.111 and PAMR p = 0.045). The difference in PAMR, but not volume, was statistically significant when analysed by linear mixed modelling. A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
CONCLUSIONS: This experimental data suggests that nipple shield use may reduce milk removal. Close clinical monitoring of breastfeeding mothers using nipple shields is warranted.
摘要：
背景：关于使用乳头罩（NS）减少乳汁转移的担忧是基于具有方法学缺陷的研究的证据。母乳喂养期间的乳汁去除可能受到婴儿和母亲因素的影响，而不是使用NS。这项研究的目的是控制电动吸奶器的真空强度，多个研究阶段的模式和持续时间，以确定使用NS是否会减少乳房的乳汁去除。
方法：招募了两组母乳喂养母亲（婴儿<6个月）的受试者内研究；对照组（CG）：无母乳喂养困难；疼痛组（PG）使用NS治疗持续的乳头疼痛。母亲使用Symphony真空曲线（MedelaAG）完成了三个随机的15分钟抽水课程；没有NS，已安装NS,一个小NS。当施加的真空在设定真空的20mmHg以内时,认为会话是有效的。牛奶去除被认为是泵送的牛奶体积，以及去除的可用牛奶百分比(PAMR)，其计算为泵送体积除以在泵送之前存储在乳房中的估计乳汁体积。
结果：在62个疗程（全部：n=31个配对疗程）中，PG（n=03）和CG（n=08）的11个配对疗程有效（子集）有和没有拟合NS。只有2个小屏蔽会话是有效的，因此排除了所有小屏蔽测量。对于所有数据，但对于子集数据，NS使用时的泵送量和PAMR均显着降低。（全部：体积和PAMR中位数：无NS：76.5mL，69%,已安装NS:32.1mL,分别为41％（体积p=0.002，PAMRp=0.002）；子集：体积和PAMR中位数：无NS：83.8mL，72%;拟合NS:35.2mL,40%(体积p=0.111,PAMRp=0.045)。PAMR的区别,但不是体积，当通过线性混合模型分析时，具有统计学意义。10mmHg的降低与PAMR的4.4％增加相关（p=0.017）。
结论：该实验数据表明，使用乳头罩可以减少乳汁去除。有必要对使用乳头罩的母乳喂养母亲进行密切的临床监测。
方法：招募了两组母乳喂养母亲（婴儿<6个月）的受试者内研究；对照组（CG）：无母乳喂养困难；疼痛组（PG）使用NS治疗持续的乳头疼痛。母亲使用Symphony真空曲线（MedelaAG）完成了三个随机的15分钟抽水课程；没有NS，已安装NS,一个小NS。当施加的真空在设定真空的20mmHg以内时,认为会话是有效的。牛奶去除被认为是泵送的牛奶体积，以及去除的可用牛奶百分比(PAMR)，其计算为泵送体积除以在泵送之前存储在乳房中的估计乳汁体积。
结果：在62个疗程（全部：n=31个配对疗程）中，PG（n=03）和CG（n=08）的11个配对疗程有效（子集）有和没有拟合NS。只有2个小屏蔽会话是有效的，因此排除了所有小屏蔽测量。对于所有数据，但对于子集数据，NS使用时的泵送量和PAMR均显着降低。（全部：体积和PAMR中位数：无NS：76.5mL，69%,已安装NS:32.1mL,分别为41％（体积p=0.002，PAMRp=0.002）；子集：体积和PAMR中位数：无NS：83.8mL，72%;拟合NS:35.2mL,40%(体积p=0.111,PAMRp=0.045)。PAMR的区别,但不是体积，当通过线性混合模型分析时，具有统计学意义。10mmHg的降低与PAMR的4.4％增加相关（p=0.017）。
结论：该实验数据表明，使用乳头罩可以减少乳汁去除。有必要对使用乳头罩的母乳喂养母亲进行密切的临床监测。
