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

BMC Pediatrics

Sarah A. Keim¹  Michael E. Schoeny²  Tricia J. Johnson³  Jesse J. Kwiek⁴  John A. F. Zupancic⁵  Amelia Bucek⁶  Judy E. Janes⁶  Aloka L. Patel⁶  Paula P. Meier⁷ 

[1] Center for Biobehavioral Health, The Abigail Wexner Research Institute, Nationwide Children’s Hospital, Columbus, USA;Department of Pediatrics, The Ohio State University College of Medicine, Columbus, USA;Division of Epidemiology, The Ohio State University College of Public Health, Columbus, USA;Department of Community, Systems and Mental Health Nursing, Rush University, Chicago, USA;Department of Health Systems Management, Rush University, 1700 West Van Buren Street, TOB Suite 126B, Chicago, USA;Department of Microbiology, The Center for Retrovirus Research and the Infectious Disease Institute, The Ohio State University, Columbus, USA;Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, USA;Harvard Medical School, Boston, USA;Department of Pediatrics, Rush University Medical Center, Chicago, USA;Department of Pediatrics, Rush University Medical Center, Chicago, USA;College of Nursing, Rush University, Chicago, USA;

关键词: Very low birth weight;    Very preterm;    Neonatal intensive care unit;    Mother’s own milk;    Maternal breast milk;    Economic evaluation;    Cost-effectiveness analysis;   

DOI  :  10.1186/s12887-021-03088-y

来源: Springer

【 摘 要 】

BackgroundBlack 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.MethodsThis 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).DiscussionThis 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 registrationClinicalTrials.gov: NCT04540575, registered September 7, 2020.

【 授权许可】

CC BY