Financial Support for Mothers of Premature Infants

Recruiting at 3 trial locations

Overseen By Margaret McConnell, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Harvard School of Public Health (HSPH)

Disqualifiers: Non-English/Spanish speaking, Non-resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Financial Transfers, Financial Assistance, Monetary Support for mothers of premature infants?

Research shows that financial support to Medicaid-eligible mothers increases caregiving activities for preterm infants, suggesting that financial assistance can positively impact the care provided to these infants. ^{1 2 3 4 5}

How does the treatment Financial Transfers differ from other treatments for mothers of premature infants?

Financial Transfers is unique because it provides direct monetary support to mothers of premature infants, which is not a standard medical treatment. This approach focuses on alleviating financial stress, potentially improving the overall well-being of the mother and infant, rather than addressing medical conditions directly. ^{6 7 8 9 10}

What is the purpose of this trial?

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). 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.

Research Team

Margaret Parker, MD

Principal Investigator

UMass Memorial Health

Margaret McConnell, PhD

Principal Investigator

Harvard School of Public Health (HSPH)

Eligibility Criteria

This trial is for low-income mothers with Medicaid who have given birth to preterm infants (24-33 weeks' gestation) at specific hospitals in Massachusetts and Georgia. The study aims to help these mothers spend more time in the NICU with their babies by providing financial support.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Mothers in the intervention group receive weekly financial transfers to support NICU visits and caregiving activities

Up to 18 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for outcomes such as maternal caregiving behaviors and infant health post-discharge

4-8 weeks

Post-discharge survey and follow-up visits

Treatment Details

Interventions

• Financial Transfers

Trial Overview The trial is testing if weekly financial transfers can increase visits to the NICU, reduce mothers' financial stress, and improve caregiving behaviors that benefit preterm infant health and development. It's a randomized controlled trial comparing usual care plus money versus just usual care.

Participant Groups

Group I: Financial Transfers Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials

283

Recruited

17,030,000+

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Financial support significantly increased maternal engagement in caregiving activities, with mothers receiving financial assistance being 85% more likely to provide skin-to-skin care and 36% more likely to provide breastmilk for their preterm infants in the NICU.

The study involved 46 Medicaid-eligible mothers and observed their behaviors over 703 days, but while financial support improved caregiving, it did not show a significant impact on neonatal growth or length of stay in the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Support to Medicaid-Eligible Mothers Increases Caregiving for Preterm Infants. Andrews, KG., Martin, MW., Shenberger, E., et al.[2020]

An individualized psychosocial parental support (PPS) program for parents of extremely low-birth-weight (ELBW) infants was associated with a significant reduction in the length of hospital stay (LOS), with the PPS group averaging 86 days compared to 99 days for the control group.

The study involved 41 ELBW infants, and while the PPS program showed benefits in reducing LOS, no other significant differences in short-term neonatal outcomes were observed, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial parental support programs and short-term clinical outcomes in extremely low-birth-weight infants. Nearing, GB., Salas, AA., Granado-Villar, D., et al.[2011]

A new program was developed where hospital nurses provide follow-up care to new mothers and their infants at home, addressing the gap in support after early hospital discharge.

The study compares health care costs between mother-infant pairs receiving this home care service and those who did not, highlighting the potential financial benefits of providing additional support during the postpartum period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing early discharge with home follow-up: a pilot project. Brown, SG., Johnson, BT.[2019]

The COPE program significantly reduced parental stress for parents of infants in the neonatal intensive care unit, as shown in a study with 49 parent sets (29 in the intervention group and 20 in the comparison group).

While there was no significant difference in parental depression scores or length of hospital stay, trends indicated that parents in the COPE group had lower depression scores and both groups reported over 95% satisfaction with care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Parent Empowerment Program on Parental Stress, Satisfaction, and Length of Stay in the Neonatal Intensive Care Unit. Nieves, H., Clements-Hickman, A., Davies, CC.[2021]

The COPE program significantly reduced anxiety and stress levels in Iranian mothers of premature infants in NICUs, with results showing improvement after each phase of the program (P < 0.001).

Mothers who participated in the COPE program were more actively involved in their infants' care compared to those in the control group, indicating that educational and behavioral support can enhance maternal participation and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Creating Opportunities for Parent Empowerment program on maternal stress, anxiety, and participation in NICU wards in Iran. Mianaei, SJ., Karahroudy, FA., Rassouli, M., et al.[2022]

Near-infrared spectroscopy (NIRS) and implantable Doppler (ID) devices have shown extremely high sensitivity (99.36% for NIRS and 100% for ID) in detecting failures of free tissue transfer (FTT) in reconstructive breast surgery, making them highly effective monitoring tools.

Both NIRS and ID significantly reduce FTT failure rates compared to conventional clinical assessment (CCA), indicating that these technologies not only improve patient outcomes but also potentially lower healthcare costs and reduce the workload for clinical staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Near-infrared Spectroscopy and Implantable Doppler for Postoperative Monitoring of Free Tissue Transfer for Breast Reconstruction: A Systematic Review and Meta-analysis. Berthelot, M., Ashcroft, J., Boshier, P., et al.[2022]

An experimental study tested four methods for assessing blood flow in microvascular free tissue transfers, highlighting the importance of accurate monitoring during and after surgery.

The successful use of ultrasound Doppler and laser Doppler flowmeters in clinical settings has improved the reliability of microvascular reconstructions and simplified postoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the fate of free tissue transfers. Jones, BM.[2018]

Using laser Doppler flowmetry to monitor flap perfusion can help identify at-risk flaps during reconstruction after modified radical mastectomy, potentially preventing necrosis.

In a study of 16 consecutive transverse rectus abdominis myocutaneous flaps, two flaps were identified as at risk for major loss, but after microvascular interventions, all flaps survived successfully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of TRAM flap perfusion using laser Doppler flowmetry: an adjunct to microvascular augmentation. Hallock, GG., Altobelli, JA.[2019]

A Doppler color-flow imager is an effective non-invasive tool for assessing blood flow and vascular patency in vascularized free fibula transfers, which can be challenging to evaluate.

This imaging technique can be utilized in the operating room, immediately after surgery, and for long-term follow-up, providing a permanent record of vascular anatomy and flow characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular patency of fibular free graft: assessment by Doppler color-flow imager: a case report. Stevenson, TR., Rubin, JM., Herzenberg, JE.[2016]

Color flow Doppler ultrasound is an effective monitoring technique for detecting venous and arterial insufficiency in microvascular surgery, showing sensitivity to flow rates as low as 3.0 ml/min in an experimental swine model.

In a clinical study involving 25 postoperative patients, color flow ultrasound successfully visualized microvascular conduits and predicted insufficiency before occlusion, demonstrating its potential for improving patient outcomes in plastic and reconstructive surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Color flow ultrasound for delineating microsurgical vessels: a clinical and experimental study. Amerhauser, A., Moelleken, BR., Mathes, SJ., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Financial Support to Medicaid-Eligible Mothers Increases Caregiving for Preterm Infants. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Psychosocial parental support programs and short-term clinical outcomes in extremely low-birth-weight infants. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing early discharge with home follow-up: a pilot project. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a Parent Empowerment Program on Parental Stress, Satisfaction, and Length of Stay in the Neonatal Intensive Care Unit. [2021]

5. India pubmed.ncbi.nlm.nih.gov

The effect of Creating Opportunities for Parent Empowerment program on maternal stress, anxiety, and participation in NICU wards in Iran. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Near-infrared Spectroscopy and Implantable Doppler for Postoperative Monitoring of Free Tissue Transfer for Breast Reconstruction: A Systematic Review and Meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Predicting the fate of free tissue transfers. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Assessment of TRAM flap perfusion using laser Doppler flowmetry: an adjunct to microvascular augmentation. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Vascular patency of fibular free graft: assessment by Doppler color-flow imager: a case report. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Color flow ultrasound for delineating microsurgical vessels: a clinical and experimental study. [2019]