Clinical trial NCT06362798: Effect of Support for Low-Income Mothers of Preterm Infants
Official title: Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Low; Birthweight, Extremely (999 Grams or Less)
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-04-12
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 - 34 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.


Eligibility criteria: Inclusion Criteria:

* Mother is eligible for Medicaid insurance.
* Has an infant or infants born 24 0/7-34 1/7 weeks gestation.
* Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.
* Mother is eligible to breastfeed (per hospital criteria).

Exclusion Criteria:

* Mother is not English- or Spanish-speaking.

Primary outcomes:
measure: Provision of breast milk (proportion)
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Provision of skin-to-skin care
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary outcomes:
measure: Duration of mother's milk expression
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Gestational weight-for-age
timeFrame: Extracted from medical records 1-2 weeks after discharge from the NICU
measure: Gestational length-for-age z-score
timeFrame: Extracted from medical records 1-2 weeks after discharge from the NICU
measure: Gestational head circumference
timeFrame: Extracted from medical records 1-2 weeks after discharge from the NICU
measure: Necrotizing enterocolitis (NEC)
timeFrame: Extracted from medical records 1-2 weeks after discharge from the NICU
measure: Late-onset bacterial or fungal sepsis (LOS)
timeFrame: Extracted from medical records 1-2 weeks after discharge from the NICU
measure: NICU Visitation
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Postpartum Bonding
timeFrame: Measured in the post-discharge survey within 4-8 week of infant discharge
measure: Provision of breast milk (volume)
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Breastfeeding episode
timeFrame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Maternal physical health
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Maternal mental health (anxiety)
timeFrame: Measured monthly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) and within one week of discharge form the NICU
measure: Maternal mental health (depression)
timeFrame: Measured monthly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) and within one week of discharge form the NICU
measure: Reaction Time Attention Network Test-Revised (ANT-R).
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Accuracy Performance Attention Network Test-Revised (ANT-R).
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Reaction Time Psychomotor Vigilance Task
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Accuracy Psychomotor Vigilance Task
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Happiness
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Life satisfaction
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Sleep
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Routine postpartum care
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Financial distress
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Financial hardship
timeFrame: Measured within one week of discharge form the NICU
measure: Food insecurity
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Housing instability
timeFrame: Measured within one week of discharge form the NICU
measure: Housing insecurity
timeFrame: Measured within one week of discharge form the NICU
measure: Transportation insecurity
timeFrame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
measure: Length of stay
timeFrame: Measured within one week of discharge form the NICU
measure: Mother readmission between 4-8 weeks post-discharge
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Baby readmission between 4-8 weeks post-discharge
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Mother emergency department visit between 4-8 weeks post-discharge
timeFrame: Measured at post-discharge survey between 4-8 weeks after discharge of infant from NICU
measure: Baby emergency department visit between 4-8 weeks post-discharge
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Sleep position
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Sleep location
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Breastfeeding expression continuation
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
measure: Skin-to-skin care knowledge
timeFrame: Measured within one week of discharge form the NICU
measure: Breastfeeding knowledge
timeFrame: Measured within one week of discharge form the NICU
measure: Perception of hospital experience
timeFrame: Measured between 4-8 weeks after discharge of infant from NICU
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta and Emory University
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Memorial Health
name: Margaret Parker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Margaret McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: