Effect of Support for Low-Income Mothers of Preterm Infants

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362798
• Other study ID #: IRB22-0729
• Secondary ID: 1R01HD109293-016
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2028

Study information

• Verified date: April 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: Margaret McConnell, PhD
• Phone: 203-745-8321
• Email: mmcconne[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 - 33 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mother is eligible for Medicaid insurance.
• Has an infant or infants born 24-33 weeks gestation.
• Mother is eligible to breastfeed (per hospital criteria).

Exclusion Criteria:

• Mother is not English- or Spanish-speaking.

Related Conditions & MeSH terms

• Birth Weight
• Low; Birthweight, Extremely (999 Grams or Less)
• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta and Emory University	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Baystate Medical Center	Springfield	Massachusetts
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Duration of mother's milk expression	Weeks of milk expression via direct breastfeeding or pumping.	From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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 monthly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) and within one week of discharge form the NICU
Secondary	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 Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).	Measured monthly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) and within one week of discharge form the NICU
Secondary	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.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary	Accuracy Performance Modified Flanker Task	Proportion of accurate responses on the Modified Flanker Task. 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)
Secondary	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.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary	Accuracy Psychomotor Vigilance Task	Proportion of accurate responses on the Psychomotor Vigilance Task. 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)
Secondary	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.	Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Secondary	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)
Secondary	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)
Secondary	Routine postpartum care	Number of routine postpartum follow-up visits attended by mom.	Measured between 4-8 weeks after discharge of infant from NICU
Secondary	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)
Secondary	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
Secondary	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)
Secondary	Housing instability	Number of moves family has made since their child's birth.	Measured within one week of discharge form the NICU
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Mother emergency department visit between 4-8 weeks post-discharge	The number of emergency department visits by the mother in the immediate postpartum period.	Measured at post-discharge survey between 4-8 weeks after discharge of infant from NICU
Secondary	Baby emergency department visit between 4-8 weeks post-discharge	The number of emergency department visits by the infant after discharge.	Measured between 4-8 weeks after discharge of infant from NICU
Secondary	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
Secondary	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
Secondary	Breastfeeding expression continuation	Mothers report of breastfeeding continuation.	Measured between 4-8 weeks after discharge of infant from NICU
Secondary	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
Secondary	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
Secondary	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