Effect of Support for Low-Income Mothers of Preterm Infants

Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)

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). We received supplemental funding to extend analyses to include extended postpartum maternal health outcomes. The original sample size of 420 remains the basis for the parent trial's primary and secondary NICU caregiving outcomes, while the supplemental funding (effective January 2026) enables analysis of secondary maternal health outcomes up to 12 months postpartum using an expanded analytic cohort. 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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Low; Birthweight, Extremely (999 Grams or Less)
• Intervention / Treatment: Other: Financial Transfers

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret McConnell, PhD; Phone Number: 203-745-8321; Email: mmcconne@hsph.harvard.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Children's Healthcare of Atlanta and Emory University
      • Contact: Michelle-Marie Peña, MD; Email: michelle.marie.pena@emory.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Gabriela Cordova Ramos, MD; Email: gabriela.CordovaRamos@bmc.org
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: Laura Madore, MD; Email: laura.Madore@baystatehealth.org
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Memorial Medical Center
      • Contact: Margaret Parker, MD; Email: margaret.Parker@umassmemorial.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Financial Transfers; Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a "CuddleCard" debit-card with a one- time "label" or scripted message that states: "This money is intended to help you to spend more time visiting and caring for your infant(s) in the NICU." Financial transfers will begin 1 week after birth or when the mother is discharged (whichever comes later) until the infant is discharged, except in cases where the hospitalization lasts beyond 42 weeks corrected age.	Other: Financial Transfers; Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a debit-card with a one-time "label" or scripted message that states: "This money is intended to help you to spend more time visiting and caring for your infant(s) in the NICU." Financial transfers will begin 1 week after birth or when the mother is discharged (whichever comes later) until the infant is discharged, except in cases where the hospitalization lasts beyond 42 weeks corrected age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provision of breast milk (proportion)	Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Provision of skin-to-skin care	Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight-for-age	Change in sex-specific gestational weight-for-age z-score while admitted to the NICU.	Extracted from medical records 1-2 weeks after discharge from the NICU
Gestational length-for-age z-score	Change in sex-specific gestational length-for-age z-score while admitted to the NICU.	Extracted from medical records 1-2 weeks after discharge from the NICU
Gestational head circumference	Change in sex-specific gestational head circumference z-score while admitted to the NICU.	Extracted from medical records 1-2 weeks after discharge from the NICU
Necrotizing enterocolitis (NEC)	Experienced NEC during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no.	Extracted from medical records 1-2 weeks after discharge from the NICU
Late-onset bacterial or fungal sepsis (LOS)	Experienced with LOS during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no.	Extracted from medical records 1-2 weeks after discharge from the NICU
NICU Visitation	Proportion of nursing shifts where mother is present in the NICU.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Postpartum Bonding	Score of mother-infant bonding assessed inspired by the Postpartum Bonding Questionnaire, where participants rate their agreement of statements on Likert scales ranging from 0 (always) to 5 (never); scores range from 0 to 50, with higher scores indicating more bonding challenges.	Measured in the post-discharge survey within 4-8 week of infant discharge
Provision of breast milk (volume)	Milliliters of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Breastfeeding episode	Occurrence of direct breastfeeding episode during each nursing shift.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Length of stay	The total number of days from infant admission to discharge from the hospital.	Measured within one week of discharge form the NICU
Mother readmission between 4-8 weeks post-discharge	Any mother readmission to the hospital after her initial discharge.	Measured between 4-8 weeks after discharge of infant from NICU
Baby readmission between 4-8 weeks post-discharge	Any infant readmission to the hospital after initial discharge.	Measured between 4-8 weeks after discharge of infant from NICU
Sleep position	Mothers report of exclusive infant supine position to sleep in the last two weeks.	Measured between 4-8 weeks after discharge of infant from NICU
Sleep location	Mothers report exclusively using the room-sharing sleep method, where the infant sleeps in the same room as an adult but on a separate crib or sleep surface, without bed-sharing, in the last two weeks.	Measured between 4-8 weeks after discharge of infant from NICU
Breastfeeding expression continuation	Mothers report of breastfeeding continuation.	Measured between 4-8 weeks after discharge of infant from NICU
Skin-to-skin care knowledge	Mothers report of knowledge about Skin-to-skin (STS) care based on 4 questions. Scored as a count variable that ranges between 0 and 4.	Measured within one week of discharge form the NICU
Breastfeeding knowledge	Mothers report of knowledge about breastfeeding based on 7 questions. Scored as a count variable that ranges between 0 and 7.	Measured within one week of discharge form the NICU
Perception of hospital experience	Assesses mothers' overall perception of hospital experience and hospital services during their stay, using a scale from 0 (worst hospital possible) to 10 (best hospital possible).	Measured between 4-8 weeks after discharge of infant from NICU
Reaction Time Attention Network Test-Revised (ANT-R).	Average response time across all trials to assess overall speed of responses. Lower scores indicate faster reaction times and better attentional performance.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Accuracy Performance Attention Network Test-Revised (ANT-R).	Proportion of accurate responses on the ANT-R. Higher scores indicate higher accurate responses.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Reaction Time Psychomotor Vigilance Task	Average reaction time across trials, assessing overall speed and vigilance. Lower scores indicate quicker reaction times and heightened vigilance.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Accuracy Psychomotor Vigilance Task	Percentage of correct responses out of the total number of trials on the Psychomotor Vigilance Task (PVT). Higher scores indicate higher accurate responses.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Duration of mother's milk expression	Months of milk expression via direct breastfeeding or pumping.	From NICU admission through to 12 months postpartum
Maternal physical health	Score of self-reported Short Form Health Survey -1 Physical Health Item; assesses participants' perception of their current physical health. Lower score indicates worse perceived physical health.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Maternal mental health (anxiety)	Score of self-reported 10-item Perceived Stress Scale (PSS-10); assesses the perceived stress levels experienced in terms of overstrain, unmanageability, and unpredictability in the past month. Higher score indicates worse outcome.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Maternal mental health (depression)	Score of the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure of postpartum depression (ranges from 0-30) with a higher score indicating worse depressive symptoms. The EPDS was developed to assist health professionals in detecting mothers suffering from postpartum depression (PPD).	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Happiness	Score on Happiness Indicator from Integrated Values Surveys; assesses the overall and current perceived level of happiness experienced; with a 4-point scale from 0 (Not at all happy) to 3 (Very Happy). Higher score indicates better perceived level of happiness.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Life satisfaction	Score of the Life Satisfaction Scale Item; assesses participants' perception of their current overall life satisfaction; with a 4-point scale from 0 (Very Satisfied) to 3 (Not At All Satisfied), and was reverse-coded such that higher scores indicate better perceived life satisfaction.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Sleep	Score of Sleep Quality Score (SQS) with 7-Day Recall; evaluates the overall quality of sleep. Core components include sleep duration, ease of falling asleep, frequency of waking during the night (excluding bathroom visits), early waking, and sleep refreshment. The respondent marks an integer score from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent. Higher score indicates better perceived sleep quality.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Routine postpartum care	Number of routine postpartum follow-up visits attended by mom.	Measured at post-discharge (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Financial distress	Score of financial stress during the NICU stay based on two metrics: difficulty in paying bills and remaining money at the end of the week. Scoring for each question is summed to create an overall financial distress score, ranging from 0 to 8. Higher score indicates higher financial distress.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Financial hardship	Score of financial hardships experienced during the NICU stay, including using up all savings, taking out loans, borrowing from friends, incurring debt, being threatened by eviction, or having a shut-off of an energy utility. Scoring for each question is yes/no and is summed to create an overall score that ranges between 0 and 6.	Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Food insecurity	Score of Food Insecurity Screening Tool; assesses the risk of food insecurity (availability and affordability) in households based on questions derived from the U.S. Household Food Security Survey Module. Response options include: "Often True," "Sometimes True," "Never True". An affirmative response on either item will be considered to be positive for food insecurity.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Housing instability	Number of moves family has made since their child's birth.	Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Housing insecurity	Score on housing insecurity scale; assesses participants' worry that they may not have stable housing in the next 2 months. Likert scales ranging from 0 (not at all worried) to 3 (very worried). Higher scores indicate greater levels of housing insecurity.	Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Transportation insecurity	Score on transportation insecurity item; assesses participants' experience of transportation-related issues affecting their ability to visit the NICU. Likert scales ranging from 0 (never) to 3 (always). Higher scores indicate greater levels of transportation insecurity.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Mother emergency department visit post-discharge	The number of emergency department visits by the mother in the postpartum period.	Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Baby emergency department visit weeks post-discharge	The number of emergency department visits by the infant after discharge.	Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum
Life's Essential 8 (LE8) behavioral cardiovascular health score	Composite score (0-100) based on four behavioral components: diet quality, physical activity, sleep health, and nicotine exposure, scored according to American Heart Association Life's Essential 8 criteria.	Measured at pre-discharge; post-discharge (4-8 weeks, where all components are available); 6 months postpartum; 12 months postpartum
Primary care utilization in the postpartum period	Number of visits with a primary care provider for routine or sick care.	Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Adherence to recommended care for chronic conditions	Self-reported adherence to recommended postpartum care for chronic conditions (hypertension, diabetes, and mental health), including medication adherence and engagement with healthcare providers for condition management.	Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Margaret McConnell, PhD, Harvard School of Public Health (HSPH); Principal Investigator: Margaret Parker, MD, UMass Memorial Health

Publications and helpful links

General Publications

• McConnell M, Alsager A, Fuchu P, Sriprasad S, Simoncini L, Drainoni ML, Cordova-Ramos EG, Pena MM, Madore L, Kalluri NS, Silverstein M, Schofield H, Farah MJ, Fink G, Parker MG. 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). BMC Pediatr. 2025 May 15;25(1):383. doi: 10.1186/s12887-025-05621-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Premature Birth; Birth Weight
• Other Study ID Numbers: Study00001150; 1R01HD109293-01 (U.S. NIH Grant/Contract); 6-23FY-0012 (Other Grant/Funding Number: March of Dimes)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No