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&lt；1500克)婴儿免受早产儿特有疾病的影响，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，极低出生体重儿的母亲往往表现出乳汁生成延迟的第二阶段(当乳汁“进来”时)和母乳产量不足。一些小型观察性研究已经将分娩后母乳表达的早期启动与更多的乳汁产量联系在一起。然而，还没有研究最终确定母乳分泌的最佳时机，以增加产奶量或减少产乳第二阶段的时机。如果没有这些证据，就无法制定实践指南来指导想要为极低出生体重婴儿提供母乳的母亲，这些母亲将继续为婴儿食用的母乳产量不足而苦苦挣扎。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儿母亲母乳产量的策略，以增加其早产儿的母乳消耗量。这项拟议的研究将跟踪一组前瞻性队列(N=189)，这些母亲来自不同种族和经济背景的极低出生体重儿，在分娩后6周内检验1个基本假设和2个探索性假设。主要假设如下：分娩后较早地开始母乳表达与(1)较早的泌乳第二阶段，以及(2)前6周内较大的乳汁产生量有关。探索性假说I与以下几点有关：较早开始母乳表达与婴儿在住院和出院时摄入较大比例的母乳有关。探索性假设2如下：在23-27周出生的婴儿和28-32周出生的婴儿中，分娩后较早开始母乳表达与前6周的产奶量较大有关。根据婴儿的妊娠情况进行分层 根据年龄，符合条件的妇女将被随机分配到三组中的一组，并被指示在分娩后第一小时、1-3小时或3-6小时开始机械地表达她们的乳房。将记录产乳第二阶段的时间，并测量前6周的母乳产量。婴儿每周和出院时消耗的母乳百分比将被测量。预计结果将填补关于乳汁分泌开始时间对乳量的影响、极低出生体重儿母亲乳汁生成第二阶段的时间以及其婴儿在住院和出院时接受母乳数量的研究的一个重要空白。研究结果还有望提供新的证据，说明不同孕周分娩婴儿的母亲较早开始哺乳的影响。

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.