Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Melatonin concentration in breast milk
研究概览
简要总结
This research is being done to understand better how a mother's 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.
详细描述
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 mother's emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mother's 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Possess a refrigerator with a freezer or a standalone freezer for sample storage at home.
- •Ability to be contacted by telephone.
- •Having internet access at home.
- •Being in the immediate (0-14 days) postpartum period.
- •Currently breastfeeding or planning to breastfeed, regardless of the type.
排除标准
- •Newborns with congenital malformations.
- •Newborns with birth weights less than 2,500g or greater than 4,000g.
- •Gestational age less than 37 completed weeks or greater than 42 completed weeks.
- •Mothers hospitalized in an intensive care unit (ICU).
- •Newborns hospitalized in the neonatal intensive care unit (NICU) or special care nursery (SCN).
- •Mothers using sleep aids (e.g., Benadryl, Unisom, Melatonin, Valerian).
- •Mothers currently being treated for pharmacologically treated mood and sleep disorders.
- •Mothers with acute infections longer than 7 days postpartum. Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.
研究组 & 干预措施
Breasting Feeding Mothers
New mothers in the immediate postpartum period and breastfeeding their newborn will be asked to collect a sample of breast milk at 14 days postpartum between 6 am and 9 am. In addition to providing a breast milk sample, they will complete a series of questionnaires related to their emotional well-being and lifestyles.
结局指标
主要结局
Melatonin concentration in breast milk
时间窗: 14 days postpartum
Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
sIgA concentration in breast milk
时间窗: 14 days postpartum
concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
次要结局
- Sleep Quality(14 days postpartum)
- Fatigue(14 days postpartum)
- Anxiety Symptoms(14 days postpartum)
- Depression Symptoms(14 days postpartum)
研究者
Ganesh Namachivayam
Principal Investigator
Mayo Clinic