Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362798
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-22
Brief Title:
Effect of Support for Low-Income Mothers of Preterm Infants
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit NICU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6-23FY-0012 | OTHER_GRANT | March of Dimes | httpsreporternihgovquickSearch1R01HD109293-01 |
| 1R01HD109293-01 | NIH | None | None |