Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393296
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
A Study of Melatonin Concentration During Lactation
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Melatonin and Secretory Immunoglobulin A sIgA Concentration During Lactation Maternal Determinants and Repercussions
Status:
RECRUITING
Status Verified Date:
2024-04
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 research is being done to understand better how a mothers emotional well-being and lifestyle such as her levels of stress fatigue depression anxiety sleep quality and eating habits might affect the levels of melatonin and sIgA in her breast milk
Detailed Description:
This study aims to learn more about promoting mothers and babies health by studying various maternal factors Gaining a better understanding of the connections between a mothers emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mothers well-being
Participants will be involved in the study during the immediate postpartum period They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby which may affect melatonin levels
In addition to breast milk collection participants will complete a series of questionnaires related to their emotion well-being and lifestyle These questionnaires will help the research team understand how factors like stress fatigue depression anxiety sleep and dietary patterns may be associated with melatonin and sIgA levels in breast milk Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis
Participants will be involved in the study during the immediate postpartum period They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby which may affect melatonin levels
In addition to breast milk collection participants will complete a series of questionnaires related to their emotion well-being and lifestyle These questionnaires will help the research team understand how factors like stress fatigue depression anxiety sleep and dietary patterns may be associated with melatonin and sIgA levels in breast milk Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis
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