CuddleCard: Protocol for a randomized controlled trial evaluating the effect of providing financial support to low-income mothers of preterm infants on parental caregiving in the neonatal intensive care unit (NICU).

BACKGROUND

Preterm birth is a leading cause of childhood mortality and developmental disabilities, with persistent socioeconomic disparities in incidence and outcomes. Maternal presence during prolonged neonatal intensive care unit (NICU) hospitalization is critical for preterm infant health, enabling mothers to provide breast milk, directly breastfeed, and engage in skin-to-skin care-all of which promote infant physiological stability and neurodevelopment. Low-income mothers face significant barriers to visiting the NICU and participating in caregiving due to financial burdens and the psychological impact of financial stress. This randomized controlled trial aims to evaluate the effectiveness of financial transfers in promoting maternal caregiving behaviors that directly impact preterm infant health outcomes during NICU hospitalization.

METHODS

We will conduct a two-arm, single-blinded randomized controlled trial with 420 Medicaid-eligible mothers of infants born between 24 weeks 0 days to 34 weeks 1 day gestation across four Level 3 NICUs in Georgia and Massachusetts. Mothers in the intervention arm will receive standard of care enhanced with weekly financial transfers and will be informed that these funds are intended to help them spend more time with their infants in the NICU. All participants will be provided with a hospital-grade breast pump and educational materials on the benefits of breast milk and skin-to-skin care. Participants will complete surveys during their infant's hospitalization and following discharge, capturing outcomes related to maternal mental and physical health, caregiving behaviors, cognitive function, financial and socioeconomic factors, infant health and growth, and perceptions of NICU care quality. Primary outcomes are the provision of breast milk and engagement in skin-to-skin care. Secondary outcomes include infant growth and health outcomes, NICU visitation, financial and socioeconomic hardship, maternal physical and mental health measures, cognitive function, and perception of NICU care quality.

DISCUSSION

This study will provide evidence of the impact of financial transfers on maternal caregiving behaviors in the NICU, addressing critical gaps in our understanding of how financial stress affects low-income mothers. Findings may inform health policy, particularly regarding Medicaid coverage of non-medical services, and contribute to understanding how to address disparities in preterm infant care.

TRIAL REGISTRATION

The trial was prospectively registered with the American Economic Association Trial Registry, the primary registry for academic economists conducting policy trials, on 16 April 2024 (AEARCTR-0013256). It was also registered on ClinicalTrials.gov (NCT06362798) on 10 April 2024.