Preterm BirthNCT05930327
COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families
A study testing Unconditional Cash Transfer (High-Value) and Unconditional Cash Transfer (Low-Value) in people with Preterm Birth, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Unconditional Cash Transfer (High-Value) and Unconditional Cash Transfer (Low-Value)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2023to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Being tested
- Unconditional Cash Transfer (High-Value), Unconditional Cash Transfer (Low-Value)
- Keywords
- Preterm Birth, Unconditional Cash Transfers, Parental Stress, Breastfeeding
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconditional Cash Transfer (High-Value)Other
Monthly, Unconditional Cash Transfer ($325) for 4-months
Unconditional Cash Transfer (Low-Value)Other
Monthly, Unconditional Cash Transfer ($25) for 4-months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Unconditional Cash Transfer (Low-Value) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 1 year
Secondary outcomes (1)
Lived experiences of caring for a preterm infant admitted to the neonatal intensive care unit.
Birthing parents' perspectives and measures of birthing parent psychological stress as measured through semi-structured interviews.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start26 Jul 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Andrea Duncan, MD, Principal investigator, Children's Hospital of Philadelphia/University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930327
- Sponsor's protocol ID
- 23-021011
- Other IDs
- 852454
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40216998
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families
- ClinicalTrials.gov ID
- NCT05930327
- Acronym / sponsor ID
- 23-021011
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Unconditional Cash Transfers, Parental Stress, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Value Cash Transfer | Experimental | Other: Unconditional Cash Transfer (High-Value)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. |
| Low-Value Cash Transfer | Active comparator | Other: Unconditional Cash Transfer (Low-Value)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unconditional Cash Transfer (High-Value)Monthly, Unconditional Cash Transfer ($325) for 4-months | Other | High-Value Cash Transfer |
| Unconditional Cash Transfer (Low-Value)Monthly, Unconditional Cash Transfer ($25) for 4-months | Other | Low-Value Cash Transfer |
Primary outcome
Acceptability of randomizing high-value and low-value unconditional cash transfers (UCT) to low income birthing parents of preterm infants.
Time frame: 1 year
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.
Feasibility of enrolling caregivers of preterm infants in the study procedures and receipt of UCTs.
Time frame: 1 year
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 secondary outcome
Lived experiences of caring for a preterm infant admitted to the neonatal intensive care unit.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 40216998Bouchelle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Duncan, MD principal investigator
Children's Hospital of Philadelphia/University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconditional Cash Transfer (High-Value) and Unconditional Cash Transfer (Low-Value) in people with Preterm Birth, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of randomizing high-value and low-value unconditional cash transfers (UCT) to low income birthing parents of preterm infants. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.