Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563726
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Sodium Awareness in Lactation Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Partnering With Parents for Pumping Success Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALT
Brief Summary:
SALT is a multi-centre non-blinded non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium Na using point-of-care POC meters A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population
Primary Objective Establish feasibility acceptance and time cost of parent-led parent milk Na testing in the first 14 days postpartum
Secondary Objective Further investigate relationships between pumping behaviours lactation risk factors daily milk Na and lactation outcomes
Exploratory Objective Explore how POC Na data may be used to modify pumping behaviour and milk volumes
Primary Objective Establish feasibility acceptance and time cost of parent-led parent milk Na testing in the first 14 days postpartum
Secondary Objective Further investigate relationships between pumping behaviours lactation risk factors daily milk Na and lactation outcomes
Exploratory Objective Explore how POC Na data may be used to modify pumping behaviour and milk volumes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None