极低出生体重儿接受母亲自身母乳的差异减少研究方案（ReDiMOM）：一项提高持续使用吸奶器依从性的随机试验
Study protocol for reducing disparity in receipt of mother's own milk in very low birth weight infants (ReDiMOM): a randomized trial to improve adherence to sustained maternal breast pump use.
作者信息
Johnson Tricia J, Meier Paula P, Schoeny Michael E, Bucek Amelia, Janes Judy E, Kwiek Jesse J, Zupancic John A F, Keim Sarah A, Patel Aloka L
机构信息
Department of Health Systems Management, Rush University, 1700 West Van Buren Street, TOB Suite 126B, Chicago, USA.
Department of Pediatrics, Rush University Medical Center, Chicago, USA.
出版信息
BMC Pediatr. 2022 Jan 7;22(1):27. doi: 10.1186/s12887-021-03088-y.
BACKGROUND
Black very low birth weight (VLBW; < 1500 g birth weight) and very preterm (VP, < 32 weeks gestational age, inclusive of extremely preterm, < 28 weeks gestational age) infants are significantly less likely than other VLBW and VP infants to receive mother's own milk (MOM) through to discharge from the neonatal intensive care unit (NICU). The costs associated with adhering to pumping maternal breast milk are borne by mothers and contribute to this disparity. This randomized controlled trial tests the effectiveness and cost-effectiveness of an intervention to offset maternal costs associated with pumping.
METHODS
This randomized control trial will enroll 284 mothers and their VP infants to test an intervention (NICU acquires MOM) developed to facilitate maternal adherence to breast pump use by offsetting maternal costs that serve as barriers to sustaining MOM feedings and the receipt of MOM at NICU discharge. Compared to current standard of care (mother provides MOM), the intervention bundle includes three components: a) free hospital-grade electric breast pump, b) pickup of MOM, and c) payment for opportunity costs. The primary outcome is infant receipt of MOM at the time of NICU discharge, and secondary outcomes include infant receipt of any MOM during the NICU hospitalization, duration of MOM feedings (days), and cumulative dose of MOM feedings (total mL/kg of MOM) received by the infant during the NICU hospitalization; maternal duration of MOM pumping (days) and volume of MOM pumped (mLs); and total cost of NICU care. Additionally, we will compare the cost of the NICU acquiring MOM versus NICU acquiring donor human milk if MOM is not available and the cost-effectiveness of the intervention (NICU acquires MOM) versus standard of care (mother provides MOM).
DISCUSSION
This trial will determine the effectiveness of an economic intervention that transfers the costs of feeding VLBWand VP infants from mothers to the NICU to address the disparity in the receipt of MOM feedings at NICU discharge by Black infants. The cost-effectiveness analysis will provide data that inform the adoption and scalability of this intervention.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04540575 , registered September 7, 2020.
背景
出生体重极低（VLBW；出生体重<1500克）和极早产（VP，胎龄<32周，包括极早产儿，胎龄<28周）的婴儿比其他VLBW和VP婴儿通过新生儿重症监护病房（NICU）出院前获得母亲自身母乳（MOM）的可能性显著更低。坚持挤母乳的相关成本由母亲承担，这加剧了这种差异。这项随机对照试验旨在测试一项干预措施的有效性和成本效益，该干预措施用于抵消与挤母乳相关的母亲成本。
方法
这项随机对照试验将招募284名母亲及其VP婴儿，以测试一项干预措施（NICU获取MOM），该措施旨在通过抵消作为维持MOM喂养和在NICU出院时获得MOM的障碍的母亲成本，来促进母亲坚持使用吸奶器。与当前的护理标准（母亲提供MOM）相比，干预方案包括三个组成部分：a）免费的医院级电动吸奶器，b）收取MOM，c）支付机会成本。主要结局是婴儿在NICU出院时接受MOM，次要结局包括婴儿在NICU住院期间接受任何MOM的情况、MOM喂养的持续时间（天）以及婴儿在NICU住院期间接受MOM喂养的累积剂量（MOM的总毫升/千克）；母亲挤MOM的持续时间（天）和挤出的MOM量（毫升）；以及NICU护理的总成本。此外，如果没有MOM，我们将比较NICU获取MOM与NICU获取捐赠人乳的成本，以及干预措施（NICU获取MOM）与护理标准（母亲提供MOM）的成本效益。
讨论
这项试验将确定一项经济干预措施的有效性，该措施将喂养VLBW和VP婴儿的成本从母亲转移到NICU，以解决黑人婴儿在NICU出院时接受MOM喂养方面的差异。成本效益分析将提供数据，为该干预措施的采用和可扩展性提供参考。
试验注册
ClinicalTrials.gov：NCT04540575，于2020年9月7日注册。
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