nctId: NCT06362798 id: IRB22-0729 id: 1R01HD109293-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD109293-01 id: 6-23FY-0012 type: OTHER_GRANT domain: March of Dimes briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-15 name: Harvard School of Public Health (HSPH) class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: 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. The investigators will conduct an randomized controlled trial (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, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers 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). The 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. conditions: Preterm Birth conditions: Low; Birthweight, Extremely (999 Grams or Less) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.) whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Financial Transfers measure: Provision of breast milk (proportion) measure: Provision of skin-to-skin care measure: Duration of mother's milk expression measure: Gestational weight-for-age measure: Gestational length-for-age z-score measure: Gestational head circumference measure: Necrotizing enterocolitis (NEC) measure: Late-onset bacterial or fungal sepsis (LOS) measure: NICU Visitation measure: Postpartum Bonding measure: Provision of breast milk (volume) measure: Breastfeeding episode measure: Maternal physical health measure: Maternal mental health (anxiety) measure: Maternal mental health (depression) measure: Reaction Time Modified Flanker Task measure: Accuracy Performance Modified Flanker Task measure: Reaction Time Psychomotor Vigilance Task measure: Accuracy Psychomotor Vigilance Task measure: Happiness measure: Life satisfaction measure: Sleep measure: Routine postpartum care measure: Financial distress measure: Financial hardship measure: Food insecurity measure: Housing instability measure: Housing insecurity measure: Transportation insecurity measure: Length of stay measure: Mother readmission between 4-8 weeks post-discharge measure: Baby readmission between 4-8 weeks post-discharge measure: Mother emergency department visit between 4-8 weeks post-discharge measure: Baby emergency department visit between 4-8 weeks post-discharge measure: Sleep position measure: Sleep location measure: Breastfeeding expression continuation measure: Skin-to-skin care knowledge measure: Breastfeeding knowledge measure: Perception of hospital experience sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Healthcare of Atlanta and Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Michelle-Marie Peña, MD role: CONTACT email: michelle.marie.pena@emory.edu lat: 33.749 lon: -84.38798 facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Gabriela Cordova Ramos, MD role: CONTACT email: gabriela.CordovaRamos@bmc.org lat: 42.35843 lon: -71.05977 facility: Baystate Medical Center city: Springfield state: Massachusetts zip: 01199 country: United States name: Laura Madore, MD role: CONTACT email: laura.Madore@baystatehealth.org lat: 42.10148 lon: -72.58981 facility: UMass Memorial Medical Center city: Worcester state: Massachusetts zip: 01605 country: United States name: Margaret Parker, MD role: CONTACT email: margaret.Parker@umassmemorial.org lat: 42.26259 lon: -71.80229 hasResults: False