A Study of Melatonin Concentration During Lactation (NCT06393296) | Clinical Trial Compass
CompletedNot Applicable
A Study of Melatonin Concentration During Lactation
United States88 participantsStarted 2024-04-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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.
Exclusion criteria:
* 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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.