COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families

NCT ID: NCT05930327

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2023-11-14

Brief Summary

The investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single neonatal intensive care unit (NICU) in Pennsylvania.

The investigators will measure the feasibility and acceptability of the intervention, birthing parents' lived experiences of having a preterm infant and the impacts of cash transfers, and conduct a preliminary assessment of efficacy on birthing parent psychological stress and ability to invest in their infant's care.

Detailed Description

Poverty is an important social determinant of health and contributes to child heath disparities. Among preterm infants, low-income is associated with worse long-term health outcomes. Given the connection between poverty and poor health outcomes, an urgent need exists to move beyond describing health disparities for low-income infants and towards interventions that interrupt these pathways in early childhood to improve outcomes.

A growing body of literature suggests that monthly unconditional cash transfers (UCTs) - no strings attached monthly cash payments - to low-income families may be an effective intervention to reduce poverty and financial stress, improve psychological health, and improve child health outcomes. However, current studies on UCTs focus primarily on term infants or heterogenous samples of children, with only a single pilot delivering direct financial assistance to low-income preterm infants. Thus, despite well-documented disparities in outcomes for low-income preterm infants, the impact of UCTs among low-income preterm infants and their families remains unknown.

Toward that end, the investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single NICU in Pennsylvania. The investigators have three specific aims:

Aim 1: To determine the feasibility and acceptability of randomizing high-value ($325/month) and low-value ($25/month) UCTs to low-income birthing parents of preterm infants beginning in the first month of life.

Aim 2: To examine birthing parents' lived experiences managing the financial impact of having a preterm infant and the perceived impact.

Exploratory Aim 3: To conduct a preliminary assessment of the efficacy of monthly UCTs on birthing parent psychological stress and ability to invest in their infant's care, recognizing the pilot is not designed to be powered for statistical significance.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-Value Cash Transfer

Participants in the treatment group will receive four $325 payments. The first payment will be disbursed at the time of enrollment (between birth and 4 weeks of age), and second payment on the infant's one-month birthday, third payment on the infant's two-month birthday, and the fourth payment on the infant's three-month birthdays.

Group Type: EXPERIMENTAL

Unconditional Cash Transfer (High-Value)

Intervention Type: OTHER

Monthly, Unconditional Cash Transfer ($325) for 4-months

Low-Value Cash Transfer

Participants in the control group will receive four $25 payments. The first payment will be disbursed at the time of enrollment (between birth and 4 weeks of age), and second payment on the infant's one-month birthday, third payment on the infant's two-month birthday, and the fourth payment on the infant's three-month birthdays.

Group Type: ACTIVE_COMPARATOR

Unconditional Cash Transfer (Low-Value)

Intervention Type: OTHER

Monthly, Unconditional Cash Transfer ($25) for 4-months

Interventions

Unconditional Cash Transfer (High-Value)

Monthly, Unconditional Cash Transfer ($325) for 4-months

Intervention Type: OTHER

Unconditional Cash Transfer (Low-Value)

Monthly, Unconditional Cash Transfer ($25) for 4-months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Medicaid-insured or uninsured by meets income requirements for Medicaid-eligibility, Over 18 years old, Speaks English or Spanish fluently, Lives in Philadelphia county, Has an infant born >=22 and <36 weeks gestational age

Exclusion Criteria

• Reports being "highly likely" to move to a different state in the next 12 months, Reports planning to place the infant up for adoption at the time of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Duncan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia/University of Pennsylvania

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Bouchelle ZM, Nelin TD, Salazar EG, Ragland S, Uwawuike D, Radack JK, Duncan AF. Unconditional cash transfers to low-income preterm infants and their families: a pilot randomized controlled trial. J Perinatol. 2025 Sep;45(9):1233-1239. doi: 10.1038/s41372-025-02293-2. Epub 2025 Apr 11.

Reference Type: DERIVED

PMID: 40216998 (View on PubMed)

Other Identifiers

852454

Identifier Type: OTHER

Identifier Source: secondary_id

23-021011

Identifier Type: -

Identifier Source: org_study_id