Preterm BirthNCT06362798
Effect of Support for Low-Income Mothers of Preterm Infants
A study testing Financial Transfers in people with Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), run by University of Massachusetts, Worcester at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
- What is being tested?
- Financial Transfers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Oct 2024to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Mother is not English- or Spanish-speaking.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, 30322
Michelle-Marie Peña, MD, michelle.marie.pena@emory.edu
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Gabriela Cordova Ramos, MD, gabriela.CordovaRamos@bmc.org
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Laura Madore, MD, laura.Madore@baystatehealth.org
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Margaret Parker, MD, margaret.Parker@umassmemorial.org
About this study
Official title: 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.
- Being tested
- Financial Transfers
- Medical subject headings
- Premature Birth, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial TransfersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Financial Transfers |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of breast milk (proportion)
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
Measured: 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.
Measured: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary outcomes (41)
Duration of mother's milk expression
Months of milk expression via direct breastfeeding or pumping.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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.
Measured: 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.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured between 4-8 weeks after discharge of infant from NICU
Breastfeeding expression continuation
Mothers report of breastfeeding continuation.
Measured: 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: 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: 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: 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: 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: 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: Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start24 Oct 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Margaret Parker, University of Massachusetts, Worcester
- Investigators
- Margaret Parker, MD, Principal investigator, UMass Memorial HealthMargaret McConnell, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362798
- Sponsor's protocol ID
- Study00001150
- Other IDs
- 1R01HD109293-01, 6-23FY-0012
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40375176