Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

描述（由申请人提供）：有令人信服的证据表明，母乳有助于保护极低出生体重（VLBW;出生体重<1500 g）婴儿免受早产特异性疾病的影响，包括喂养不耐受、迟发性败血症和坏死性小肠结肠炎。不幸的是，极低出生体重婴儿的母亲往往表现出延迟的第二阶段（当牛奶“进来”）和母乳生产不足。几项小型观察性研究将分娩后较早开始乳汁分泌与更多的乳汁产量联系起来。然而，没有研究最终确定母乳表达的最佳时机，以增加牛奶产量或减少第二阶段的时间。如果没有这些证据，就无法制定实践指南来指导那些希望为极低出生体重婴儿提供母乳的母亲，这些母亲将继续与婴儿消费的牛奶产量不足作斗争。这项为期3年的研究的总体目标是确定一种提高极低出生体重婴儿母亲母乳产量的策略，以增加早产极低出生体重婴儿的母乳消耗。拟议的研究将跟踪一个前瞻性队列（N = 189）的种族和经济上不同的母亲的VLBW婴儿6周后交付，以测试1个主要假设和2个探索性假设。主要假设与以下相关：分娩后较早开始乳汁分泌与（1）较早的乳汁生成阶段II相关，以及（2）前6周内更大的乳汁分泌量相关。探索性假设I与以下内容相关：较早开始乳汁分泌与婴儿在住院期间和出院时消耗的母乳百分比较高相关。探索性假设2如下：分娩后较早开始母乳分泌与妊娠23-27周出生的婴儿和妊娠28-32周出生的婴儿在前6周内的产奶量较大相关。根据婴儿的妊娠期分层后 年龄，合格的妇女将被随机分配到三个组之一，并指示开始机械地表达他们的乳房，无论是在第一个小时，1-3小时，或3-6小时后交付。将记录第II阶段泌乳的时间，并测量前6周的母乳产量。将测量婴儿每周和出院时摄入的母乳百分比。结果预计将填补一个重要的空白，在研究的影响，开始挤奶的时间对牛奶量，和时间的第二阶段的催乳作用在母亲的VLBW婴儿和母乳量的婴儿在住院期间和出院。研究结果还有望提供新的证据，说明在不同胎龄分娩婴儿的母亲中，较早开始乳汁分泌的影响。

DESCRIPTION (provided by applicant): Compelling evidence exists that breast milk helps protect very low birthweight (VLBW; birthweight <1500 g) infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Several small observational studies have linked earlier initiation of breast milk expression following delivery with greater milk production. However, no research has conclusively determined the optimal timing of breast milk expression to increase milk production or decrease timing of lactogenesis stage II. Without this evidence, practice guidelines cannot be developed to guide mothers who want to provide breast milk to their VLBW infants, and these mothers will continue to struggle with inadequate milk production for infant consumption. The overall objective of this 3-year study is to identify a strategy for enhancing breast milk production in mothers of VLBW infants to increase consumption of breast milk by their premature VLBW infants. The proposed study will follow a prospective cohort (N = 189) of racially and economically diverse mothers of VLBW infants for 6 weeks following delivery to test 1 primary hypothesis and 2 exploratory hypotheses. The primary hypotheses are related to the following: Earlier initiation of breast milk expression following delivery is associated with (1) earlier lactogenesis stage II, and (2) greater volume of breast mil production during the first 6 weeks. Exploratory hypothesis I is related to the following: Earlier initiation of breast milk expression is associated with a greater percentage of breast milk consumed by the infant during hospitalization and at discharge. Exploratory hypotheses 2 is as follows: Earlier initiation of breast milk expression following delivery is associated with a greatr volume of milk production during the first 6 weeks in infants born at 23-27 weeks gestation and those born at 28-32 weeks gestation. Following stratification according to the infant's gestational age, eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their breasts, either in the first hour, 1-3 hours, or 3-6 hours following delivery. Timing of lactogenesis stage II will be documented, and volume of breast milk produced will be measured for the first 6 weeks. The percentage of breast milk the infant consumes weekly and at discharge will be measured. Results are expected to fill an important gap in research regarding the impact of timing of initiation of milk expression on milk volume, and timing of lactogenesis stage II in mothers of VLBW infants and the amount of breast milk their infant receives during hospitalization and at discharge. Results are also expected to provide new evidence regarding the impact of earlier initiation of milk expression in mothers delivering infants at differing gestational ages.