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

NCT05930327 | Completed

• 2 other identifiers: 23-021011852454
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Birth

Keywords

Preterm Birth; Unconditional Cash Transfers; Parental Stress; Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Acceptability of randomizing high-value and low-value unconditional cash transfers (UCT) to low income birthing parents of preterm infants.

  The investigators define acceptability as greater than or equal to 90% of respondents reporting "agree" to "strongly agree" to each of the 4 measures of acceptability on the follow-up surveys at 2-months.

  1 year

• Feasibility of enrolling caregivers of preterm infants in the study procedures and receipt of UCTs.

  The investigators will measure the percentage of eligible subjects enrolled in study procedures, percentage of participants eligible for cash transfers who consented to receive the cash transfers, percentage of participants receiving monthly payments delivered within 1-2 days of the the child's monthly birthday. The investigators define feasibility as greater than 60% of those eligible enrolling in the study procedures, greater than or equal to 90% of those eligible for cash transfers to consent to cash transfers, and greater than or equal to 95% of monthly payments delivered within 1-2 days on either side of the child's monthly birthday. The investigators will additionally measure the attrition rate of survey and follow-up interview completion, aiming for an attrition rate less than or equal to 20%.

  1 year

Secondary Outcomes (1)

• Lived experiences of caring for a preterm infant admitted to the neonatal intensive care unit.

  1 year

Study Arms (2)

High-Value Cash Transfer

EXPERIMENTAL

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.

Other: Unconditional Cash Transfer (High-Value)

Low-Value Cash Transfer

ACTIVE COMPARATOR

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.

Other: Unconditional Cash Transfer (Low-Value)

Interventions

Unconditional Cash Transfer (High-Value) OTHER

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

High-Value Cash Transfer

Unconditional Cash Transfer (Low-Value) OTHER

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

Low-Value Cash Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 40216998 DERIVED

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Andrea Duncan, MD

  Children's Hospital of Philadelphia/University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: July 26, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)