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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD109293-01 | U.S. NIH Grant/Contract | View source | |
| 6-23FY-0012 | Other Grant/Funding Number | March of Dimes |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Transfers | Experimental | 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. |
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| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Transfers | Other | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mother's milk expression | Months of milk expression via direct breastfeeding or pumping. | From NICU admission through to 12 months postpartum |
| Gestational weight-for-age | Change in sex-specific gestational weight-for-age z-score while admitted to the NICU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret McConnell, PhD | Contact | 203-745-8321 | mmcconne@hsph.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Margaret Parker, MD | UMass Memorial Health | Principal Investigator |
| Margaret McConnell, PhD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta and Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40375176 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001724 | Birth Weight |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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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.)
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| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| Baystate Medical Center | Recruiting | Springfield | Massachusetts | 01199 | United States |
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| UMass Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01605 | United States |
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| D000091642 | Urogenital Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |