protocolSection identificationModule nctId: NCT06362798, orgStudyIdInfo id: IRB22-0729, secondaryIdInfos id: 1R01HD109293-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HD109293-01, secondaryIdInfos id: 6-23FY-0012, type: OTHER_GRANT, domain: March of Dimes, briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Harvard School of Public Health (HSPH), class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule 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., conditionsModule conditions: Preterm Birth, conditions: Low; Birthweight, Extremely (999 Grams or Less), designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Financial Transfers, outcomesModule primaryOutcomes measure: Provision of breast milk (proportion), primaryOutcomes measure: Provision of skin-to-skin care, secondaryOutcomes measure: Duration of mother's milk expression, secondaryOutcomes measure: Gestational weight-for-age, secondaryOutcomes measure: Gestational length-for-age z-score, secondaryOutcomes measure: Gestational head circumference, secondaryOutcomes measure: Necrotizing enterocolitis (NEC), secondaryOutcomes measure: Late-onset bacterial or fungal sepsis (LOS), secondaryOutcomes measure: NICU Visitation, secondaryOutcomes measure: Postpartum Bonding, secondaryOutcomes measure: Provision of breast milk (volume), secondaryOutcomes measure: Breastfeeding episode, secondaryOutcomes measure: Maternal physical health, secondaryOutcomes measure: Maternal mental health (anxiety), secondaryOutcomes measure: Maternal mental health (depression), secondaryOutcomes measure: Reaction Time Modified Flanker Task, secondaryOutcomes measure: Accuracy Performance Modified Flanker Task, secondaryOutcomes measure: Reaction Time Psychomotor Vigilance Task, secondaryOutcomes measure: Accuracy Psychomotor Vigilance Task, secondaryOutcomes measure: Happiness, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Routine postpartum care, secondaryOutcomes measure: Financial distress, secondaryOutcomes measure: Financial hardship, secondaryOutcomes measure: Food insecurity, secondaryOutcomes measure: Housing instability, secondaryOutcomes measure: Housing insecurity, secondaryOutcomes measure: Transportation insecurity, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Mother readmission between 4-8 weeks post-discharge, secondaryOutcomes measure: Baby readmission between 4-8 weeks post-discharge, secondaryOutcomes measure: Mother emergency department visit between 4-8 weeks post-discharge, secondaryOutcomes measure: Baby emergency department visit between 4-8 weeks post-discharge, secondaryOutcomes measure: Sleep position, secondaryOutcomes measure: Sleep location, secondaryOutcomes measure: Breastfeeding expression continuation, secondaryOutcomes measure: Skin-to-skin care knowledge, secondaryOutcomes measure: Breastfeeding knowledge, secondaryOutcomes measure: Perception of hospital experience, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Healthcare of Atlanta and Emory University, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Michelle-Marie Peña, MD, role: CONTACT, email: michelle.marie.pena@emory.edu, geoPoint lat: 33.749, lon: -84.38798, locations facility: Boston Medical Center, city: Boston, state: Massachusetts, zip: 02118, country: United States, contacts name: Gabriela Cordova Ramos, MD, role: CONTACT, email: gabriela.CordovaRamos@bmc.org, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Baystate Medical Center, city: Springfield, state: Massachusetts, zip: 01199, country: United States, contacts name: Laura Madore, MD, role: CONTACT, email: laura.Madore@baystatehealth.org, geoPoint lat: 42.10148, lon: -72.58981, locations facility: UMass Memorial Medical Center, city: Worcester, state: Massachusetts, zip: 01605, country: United States, contacts name: Margaret Parker, MD, role: CONTACT, email: margaret.Parker@umassmemorial.org, geoPoint lat: 42.26259, lon: -71.80229, hasResults: False