Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945264
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-07-06
Brief Title:
Music Intervention for Preterm Birth
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This study will test a music intervention MI versus a sham control SC arm which only includes a verbal intervention to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women reduce preterm birth and improve infant outcomes
Detailed Description:
Preterm birth occurs at unacceptably high rates in the United States with Black women disproportionately affected A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination poverty and neighborhood disadvantage that Black women often experience from an early age In this interdisciplinary study the investigators bring together experts in preterm birth music therapy and metabolomics to address this health disparity by testing the efficacy of a live culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes
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 |
|---|---|---|---|
| R01MD016899 | NIH | None | httpsreporternihgovquickSearchR01MD016899 |