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

描述（由申请人提供）：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、晚发性败血症和坏死性小肠结肠炎。不幸的是，VLBW婴儿的母亲经常表现出延迟的乳汁发生阶段II（当乳汁“进来”时）和母乳分泌不足。几项小型观察性研究表明，分娩后早期开始母乳表达与产奶量增加有关。然而，还没有研究最终确定母乳表达的最佳时间来增加产奶量或减少乳发生II期的时间。如果没有这一证据，就无法制定实践指南来指导希望为其极低体重婴儿提供母乳的母亲，而这些母亲将继续与婴儿消费的奶水不足作斗争。这项为期3年的研究的总体目标是确定一种策略，以提高极低体重婴儿母亲的母乳产量，从而增加其早产儿的母乳摄入量。本研究将对一组具有不同种族和经济背景的VLBW婴儿母亲进行为期6周的前瞻性队列研究（N = 189），以检验1个主要假设和2个探索性假设。主要的假设与以下有关：分娩后母乳表达的早期开始与(1)更早的乳汁发生阶段II和(2)在前6周内更多的母乳产奶量有关。探索性假设1与以下内容有关：较早开始母乳表达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：妊娠23-27周出生的婴儿和妊娠28-32周出生的婴儿在分娩后较早开始母乳表达与前6周产奶量较大有关。以下分层根据婴儿的妊娠期

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.