A Study of Melatonin Concentration During Lactation (NCT06393296) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Melatonin Concentration During Lactation
United States120 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 range18 Years
SexFEMALE
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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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.