Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the NICU

Last registered on April 16, 2024

Pre-Trial

Trial Information

General Information

Title
Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the NICU
RCT ID
AEARCTR-0013256
Initial registration date
April 05, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 16, 2024, 1:01 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

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Primary Investigator

Affiliation
Harvard School of Public Health

Other Primary Investigator(s)

PI Affiliation
UMass Memorial Health

Additional Trial Information

Status
In development
Start date
2024-05-01
End date
2028-12-01
Secondary IDs
1R01HD109293-01
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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 - 33 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.
External Link(s)

Registration Citation

Citation
McConnell, Margaret and Margaret Parker. 2024. "Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the NICU." AEA RCT Registry. April 16. https://doi.org/10.1257/rct.13256-1.0
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Experimental Details

Interventions

Intervention(s)
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. We will conduct an RCT to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, MA, UMass Memorial Medical Center (UMass) in Worcester, MA, Baystate Medical Center in Springfield, MA, and Grady Memorial Hospital in Atlanta, GA . Mothers in the intervention arm will receive usual care enhanced with financial transfers of $160/week 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). Our 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.
Intervention Start Date
2024-05-01
Intervention End Date
2028-05-01

Primary Outcomes

Primary Outcomes (end points)
Provision of breast milk (proportion)

Provision of skin-to-skin care
Primary Outcomes (explanation)
Provision of breast milk (proportion) - Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.

Provision of skin-to-skin care - Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.

Secondary Outcomes

Secondary Outcomes (end points)
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
Secondary Outcomes (explanation)
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 Quick Inventory of Depressive Symptomatology (QIDS SR-16), a 16-item self-report measure of depression (ranges from 0-27) with a higher score indicating worse depressive symptoms. The QIDS SR-16 includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-IV.

Reaction Time Modified Flanker Task - Difference in reaction time between cued and uncued trials on correct responses. Lower scores indicate faster reaction times and better attentional performance.

Accuracy Performance Modified Flanker Task - Proportion of accurate responses on the Modified Flanker Task. Higher scores indicate higher accurate responses.

Reaction Time Psychomotor Vigilance Task - Difference in reaction time between cued and uncued trials on correct responses. 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 of the General Social Survey (GSS) Single-Item Happiness Scale; assesses the overall and current perceived level of happiness experienced; with a 3-point scale from 0 (Not Happy) to 2 (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).

Experimental Design

Experimental Design
Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers 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 of $160/week 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.
Experimental Design Details
Not available
Randomization Method
Randomization will be conducted by automated computer process.
Randomization Unit
Randomization will be stratified by hospital, multiple vs. singleton birth, and gestational age strata (24-30 and 31-33 weeks).
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
N/A
Sample size: planned number of observations
N/A
Sample size (or number of clusters) by treatment arms
Intervention Arm - 220 mothers
Control Arm - 220 mothers
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Randomization will occur at the mother level and NICU caregiving behaviors will be observed on at least 15 days of infant hospitalization. We assume within-mother correlation of breastfeeding and skin-to-skin care across days as 0.56 and 0.24 respectively based on data from a pilot trial of cash transfers in the NICU. We report minimum detectable effects (MDEs) with 90% power and significance level of 5% for a two-sided statistical test. We designed our sample size to achieve 90% power for detecting a 10 percentage-point increase in the percent of all nutritional intake that consists of mother’s milk, based on evidence that this increase would translate to statistically and clinically significant reductions in the combined risk of necrotizing enterocolitis or mortality. Using baseline data from our sites, we anticipate that the percentage of nutritional intake consisting of mother’s milk in the control group will be 59% on an average day with a standard deviation of 40% across mothers. In order to detect a 10 percentage-point increase in the percentage of daily nutritional intake that is mother’s milk, a sample size of 200 mothers per study arm is needed. Accounting for expected attrition of 5% for this outcome, we estimate that we will need to enroll a total sample of 420 mothers to achieve 90% statistical power.
IRB

Institutional Review Boards (IRBs)

IRB Name
Harvard Longwood Campus Institutional Review Board
IRB Approval Date
2023-06-16
IRB Approval Number
IRB22-0729