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Abstract
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Before
Preterm birth is the leading cause of childhood mortality and developmental disabilities and costs $26 billion annually. A critical modifier of preterm infant health and development is maternal presence during the birth hospitalization, which facilitates breast milk provision, participation in skin-to-skin care and allows mothers to benefit from training in post-discharge infant care practices. However, these benefits can only be realized if mothers are able to visit their hospitalized preterm infants for several hours per day, actively engage in caregiving and receive training from staff during the many weeks of a typical preterm birth hospitalization. Regularly visiting a neonatal intensive care unit (NICU) requires mothers to shoulder significant costs, including parking, childcare for other children, transportation, and accommodations , in addition to forgoing income. Moreover, new evidence suggests that the psychological burden of financial strain may worsen mental health outcomes (including stress and depression) and impede cognitive functions such as attention, memory, and inhibitory control, which may further impede low-income mothers’ participation in NICU caregiving. Building on a feasibility trial conducted by our team , we propose to conduct a 1:1 randomized control trial to rigorously test the impact of financial transfers versus standard of care (control) among 420 low - income mothers with infants 25 - 33 weeks’ gestation in 3 level 3 NICUs (1 urban, 1 urban/suburban and 1 suburban/rural). Mothers in the intervention arm will receive a transfer of $160 per hospital week with a one - time “label” or scripted message that explains that the transfer is intended for them to visit and care for their hospitalized infant. Our primary hypothesis is that financial transfers can enable economically disadvantaged families to visit the NICU, reduce the negative psychological impacts of financial distress, increase maternal caregiving behaviors associated with positive preterm infant health and development and potentially reduce health systems costs. In Aim 1, we will examine the imp act of financial transfers on primary NICU caregiving behaviors -- breastmilk provision and skin-to-skin care -- and secondary 1-2 month post - discharge caregiving behaviors -- safe sleep practices. In Aim 2, we will consider mechanisms of action, including mediators ( NICU visitation, mental health, and cognitive function ) of the relationship between financial transfers and caregiving behaviors of interest. We will also qualitatively explore maternal perspectives of financial transfers, mediators of its impact, and other barriers and facilitators to maternal caregiving. In Aim 3, we will conduct exploratory analysis of cost drivers (length of stay, 30 - day readmission and ED use). This simple and scalable intervention has tremendous potential to improve equity in health care access by enabling key populations to utilize existing clinical supports during the NICU hospitalization.
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After
Preterm birth is the leading cause of childhood mortality and developmental disabilities and costs $26 billion annually. A critical modifier of preterm infant health and development is maternal presence during the birth hospitalization, which facilitates breast milk provision, participation in skin-to-skin care and allows mothers to benefit from training in post-discharge infant care practices. However, these benefits can only be realized if mothers are able to visit their hospitalized preterm infants for several hours per day, actively engage in caregiving and receive training from staff during the many weeks of a typical preterm birth hospitalization. Regularly visiting a neonatal intensive care unit (NICU) requires mothers to shoulder significant costs, including parking, childcare for other children, transportation, and accommodations , in addition to forgoing income. Moreover, new evidence suggests that the psychological burden of financial strain may worsen mental health outcomes (including stress and depression) and impede cognitive functions such as attention, memory, and inhibitory control, which may further impede low-income mothers’ participation in NICU caregiving. Building on a feasibility trial conducted by our team , we propose to conduct a 1:1 randomized control trial to rigorously test the impact of financial transfers versus standard of care (control) among 420 low - income mothers with infants 25 - 34 weeks’ gestation in 3 level 3 NICUs (1 urban, 1 urban/suburban and 1 suburban/rural). Mothers in the intervention arm will receive a transfer of $160 per hospital week with a one - time “label” or scripted message that explains that the transfer is intended for them to visit and care for their hospitalized infant. Our primary hypothesis is that financial transfers can enable economically disadvantaged families to visit the NICU, reduce the negative psychological impacts of financial distress, increase maternal caregiving behaviors associated with positive preterm infant health and development and potentially reduce health systems costs. In Aim 1, we will examine the imp act of financial transfers on primary NICU caregiving behaviors -- breastmilk provision and skin-to-skin care -- and secondary 1-2 month post - discharge caregiving behaviors -- safe sleep practices. In Aim 2, we will consider mechanisms of action, including mediators ( NICU visitation, mental health, and cognitive function ) of the relationship between financial transfers and caregiving behaviors of interest. We will also qualitatively explore maternal perspectives of financial transfers, mediators of its impact, and other barriers and facilitators to maternal caregiving. In Aim 3, we will conduct exploratory analysis of cost drivers (length of stay, 30 - day readmission and ED use). This simple and scalable intervention has tremendous potential to improve equity in health care access by enabling key populations to utilize existing clinical supports during the NICU hospitalization.
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Trial Start Date
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October 15, 2024
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October 24, 2024
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Trial End Date
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December 31, 2028
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August 31, 2028
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Last Published
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September 25, 2024 09:06 PM
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March 25, 2025 03:24 PM
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Intervention (Public)
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Before
Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. We will conduct an RCT to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, MA, UMass Memorial Medical Center (UMass) in Worcester, MA, Baystate Medical Center in Springfield, MA, and Grady Memorial Hospital in Atlanta, GA . Mothers in the intervention arm will receive usual care enhanced with financial transfers of $160/week and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). Our primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.
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After
Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. We will conduct an RCT to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, MA, UMass Memorial Medical Center (UMass) in Worcester, MA, Baystate Medical Center in Springfield, MA, and Grady Memorial Hospital in Atlanta, GA . Mothers in the intervention arm will receive usual care enhanced with financial transfers of $160/week and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). Our primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.
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Intervention Start Date
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October 15, 2024
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October 24, 2024
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Intervention End Date
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July 31, 2028
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July 01, 2028
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Randomization Unit
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Before
Randomization will be stratified by hospital, multiple vs. singleton birth, and gestational age strata (24-30 and 31-33 weeks).
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After
Randomization will be stratified by hospital, multiple vs. singleton birth, and gestational age strata (24-30 and 31-34 weeks).
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