| Field | Before | After |
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| Field Abstract | Before Preterm birth is the leading cause of childhood mortality and developmental disabilities and costs $26 billion annually. A critical modifier of preterm infant health and development is maternal presence during the birth hospitalization, which facilitates breast milk provision, participation in skin-to-skin care and allows mothers to benefit from training in post-discharge infant care practices. However, these benefits can only be realized if mothers are able to visit their hospitalized preterm infants for several hours per day, actively engage in caregiving and receive training from staff during the many weeks of a typical preterm birth hospitalization. Regularly visiting a neonatal intensive care unit (NICU) requires mothers to shoulder significant costs, including parking, childcare for other children, transportation, and accommodations , in addition to forgoing income. Moreover, new evidence suggests that the psychological burden of financial strain may worsen mental health outcomes (including stress and depression) and impede cognitive functions such as attention, memory, and inhibitory control, which may further impede low-income mothers’ participation in NICU caregiving. Building on a feasibility trial conducted by our team , we propose to conduct a 1:1 randomized control trial to rigorously test the impact of financial transfers versus standard of care (control) among 420 low - income mothers with infants 25 - 34 weeks’ gestation in 3 level 3 NICUs (1 urban, 1 urban/suburban and 1 suburban/rural). Mothers in the intervention arm will receive a transfer of $160 per hospital week with a one - time “label” or scripted message that explains that the transfer is intended for them to visit and care for their hospitalized infant. Our primary hypothesis is that financial transfers can enable economically disadvantaged families to visit the NICU, reduce the negative psychological impacts of financial distress, increase maternal caregiving behaviors associated with positive preterm infant health and development and potentially reduce health systems costs. In Aim 1, we will examine the imp act of financial transfers on primary NICU caregiving behaviors -- breastmilk provision and skin-to-skin care -- and secondary 1-2 month post - discharge caregiving behaviors -- safe sleep practices. In Aim 2, we will consider mechanisms of action, including mediators ( NICU visitation, mental health, and cognitive function ) of the relationship between financial transfers and caregiving behaviors of interest. We will also qualitatively explore maternal perspectives of financial transfers, mediators of its impact, and other barriers and facilitators to maternal caregiving. In Aim 3, we will conduct exploratory analysis of cost drivers (length of stay, 30 - day readmission and ED use). This simple and scalable intervention has tremendous potential to improve equity in health care access by enabling key populations to utilize existing clinical supports during the NICU hospitalization. | After Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and in 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 a randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid-eligible mothers with infants born preterm (approximately 24–34 weeks’ gestation) across participating level 3 NICUs. 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, compared with a control arm receiving usual care. We received supplemental funding to extend analyses to include postpartum cardiovascular 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 add-on (effective January 2026) supports analysis of maternal cardiovascular outcomes up to 12 months postpartum using an expanded analytic cohort. To support meeting recruitment goals and to ensure sufficient analytic power for the supplemental maternal cardiovascular health outcomes, an additional study site was added, while maintaining the original sample size for the parent trial’s primary NICU outcomes. The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU more often, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development. |
| Field Last Published | Before March 25, 2025 03:24 PM | After January 06, 2026 06:03 PM |
| Field Public analysis plan | Before No | After Yes |
| Field Secondary Outcomes (End Points) | Before Duration of mother's milk expression Gestational weight-for-age Gestational length-for-age z-score Gestational head circumference Necrotizing enterocolitis (NEC) Late-onset bacterial or fungal sepsis (LOS) NICU Visitation Postpartum Bonding Provision of breast milk (volume) Breastfeeding episode Maternal physical health Maternal mental health (anxiety) Maternal mental health (depression) Reaction Time Modified Flanker Accuracy Performance Modified Flanker Task Reaction Time Psychomotor Vigilance Task Accuracy Psychomotor Vigilance Task Happiness Life satisfaction Sleep Routine postpartum care Financial distress Financial hardship Food insecurity Housing instability Housing insecurity Transportation insecurity Length of stay Mother readmission between 4-8 weeks post-discharge Baby readmission between 4-8 weeks post-discharge Mother ED visit between 4-8 weeks post-discharge Baby ED visit between 4-8 weeks post-discharge Sleep position Sleep location Breastfeeding expression continuation Skin-to-skin care knowledge Breastfeeding knowledge Perception of hospital experience | After Duration of mother's milk expression Gestational weight-for-age Gestational length-for-age z-score Gestational head circumference Necrotizing enterocolitis (NEC) Late-onset bacterial or fungal sepsis (LOS) NICU Visitation Postpartum Bonding Provision of breast milk (volume) Breastfeeding episode Maternal physical health Maternal mental health (anxiety) Maternal mental health (depression) Reaction Time Modified Flanker Accuracy Performance Modified Flanker Task Reaction Time Psychomotor Vigilance Task Accuracy Psychomotor Vigilance Task Happiness Life satisfaction Sleep Routine postpartum care Financial distress Financial hardship Food insecurity Housing instability Housing insecurity Transportation insecurity Length of stay Mother readmission between 4-8 weeks post-discharge Baby readmission between 4-8 weeks post-discharge Mother emergency department visit post-discharge Baby emergency department visit weeks post-discharge Sleep position Sleep location Breastfeeding expression continuation Skin-to-skin care knowledge Breastfeeding knowledge Perception of hospital experience Life’s Essential 8 (LE8) behavioral cardiovascular health score Primary care utilization in the postpartum period Adherence to recommended care for chronic conditions |
| Field Secondary Outcomes (Explanation) | Before Duration of mother's milk expression - Weeks of milk expression via direct breastfeeding or pumping. Gestational weight-for-age - Change in sex-specific gestational weight-for-age z-score while admitted to the NICU. Gestational length-for-age z-score - Change in sex-specific gestational length-for-age z-score while admitted to the NICU. Gestational head circumference - Change in sex-specific gestational head circumference z-score while admitted to the NICU. Necrotizing enterocolitis (NEC) - Experienced NEC during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no. Late-onset bacterial or fungal sepsis (LOS) - Experienced with LOS during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no. NICU Visitation - Proportion of nursing shifts where mother is present in the NICU. 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. Provision of breast milk (volume) - Milliliters of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle. Breastfeeding episode - Occurrence of direct breastfeeding episode during each nursing shift. 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. 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. 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). Reaction Time 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. Accuracy Performance Attention Network Test-Revised (ANT-R) - Proportion of accurate responses on the ANT-R. Higher scores indicate higher accurate responses. Reaction Time Psychomotor Vigilance Task - Average reaction time across trials, assessing overall speed and vigilance. Lower scores indicate quicker reaction times and heightened vigilance. Accuracy Psychomotor Vigilance Task - Proportion of accurate responses on the Psychomotor Vigilance Task. Higher scores indicate higher accurate responses. 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. 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. 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. Routine postpartum care - Number of routine postpartum follow-up visits attended by mom. 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. 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. 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. Housing instability - Number of moves family has made since their child's birth. 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. 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. Length of stay - The total number of days from infant admission to discharge from the hospital. Mother readmission between 4-8 weeks post-discharge - Any mother readmission to the hospital after her initial discharge. Baby readmission between 4-8 weeks post-discharge - Any infant readmission to the hospital after initial discharge. Mother ED visit between 4-8 weeks post-discharge - The number of emergency department visits by the mother in the immediate postpartum period. Baby ED visit between 4-8 weeks post-discharge - The number of emergency department visits by the infant after discharge. Sleep position - Mothers report of exclusive infant supine position to sleep in the last two weeks. 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. Breastfeeding expression continuation - Mothers report of breastfeeding continuation. 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. Breastfeeding knowledge - Mothers report of knowledge about breastfeeding based on 7 questions. Scored as a count variable that ranges between 0 and 7. 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). | After Duration of mother's milk expression - Months of milk expression via direct breastfeeding or pumping. Gestational weight-for-age - Change in sex-specific gestational weight-for-age z-score while admitted to the NICU. Gestational length-for-age z-score - Change in sex-specific gestational length-for-age z-score while admitted to the NICU. Gestational head circumference - Change in sex-specific gestational head circumference z-score while admitted to the NICU. Necrotizing enterocolitis (NEC) - Experienced NEC during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no. Late-onset bacterial or fungal sepsis (LOS) - Experienced with LOS during NICU stay according to Vermont Oxford Network (VON) definition; criteria: yes/no. NICU Visitation - Proportion of nursing shifts where mother is present in the NICU. 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. Provision of breast milk (volume) - Milliliters of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle. Breastfeeding episode - Occurrence of direct breastfeeding episode during each nursing shift. 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. 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. 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). Reaction Time 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. Accuracy Performance Attention Network Test-Revised (ANT-R) - Proportion of accurate responses on the ANT-R. Higher scores indicate higher accurate responses. Reaction Time Psychomotor Vigilance Task - Average reaction time across trials, assessing overall speed and vigilance. Lower scores indicate quicker reaction times and heightened vigilance. Accuracy Psychomotor Vigilance Task - Proportion of accurate responses on the Psychomotor Vigilance Task. Higher scores indicate higher accurate responses. 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. 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. 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. Routine postpartum care - Number of routine postpartum follow-up visits attended by mom. 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. 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. 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. Housing instability - Number of moves family has made since their child's birth. 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. 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. Length of stay - The total number of days from infant admission to discharge from the hospital. Mother emergency department visit post-discharge - Any mother readmission to the hospital after her initial discharge. Baby emergency department visit weeks post-discharge - Any infant readmission to the hospital after initial discharge. Mother ED visit between 4-8 weeks post-discharge - The number of emergency department visits by the mother in the immediate postpartum period. Baby ED visit between 4-8 weeks post-discharge - The number of emergency department visits by the infant after discharge. Sleep position - Mothers report of exclusive infant supine position to sleep in the last two weeks. 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. Breastfeeding expression continuation - Mothers report of breastfeeding continuation. 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. Breastfeeding knowledge - Mothers report of knowledge about breastfeeding based on 7 questions. Scored as a count variable that ranges between 0 and 7. 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). 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. Primary care utilization in the postpartum period - Number of visits with a primary care provider for routine or sick care. 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. |
| Field | Before | After |
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| Field Document | Before |
After
AEA_CT_Pre-Analysis_Plan_v12132025 MM.docx
MD5:
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SHA1:
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