Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 3:23 PM
Study NCT ID:
NCT06691932
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2024-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Status:
RECRUITING
Status Verified Date:
2025-12
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:
BEGIN
Brief Summary:
The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HD112363 | NIH | None | https://reporter.nih.gov/quic… | View |