A Study of Melatonin Concentration During Lactation

Launched by MAYO CLINIC · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a mother's emotional health and daily habits—like stress, fatigue, sleep quality, and eating—can affect the levels of melatonin and a specific immune protein called sIgA in her breast milk. Melatonin is a hormone that helps regulate sleep, and sIgA plays a role in protecting babies from infections. By understanding these connections, the researchers hope to learn more about how a mother's lifestyle during breastfeeding may impact her baby's health.

To participate, mothers should be in the early days after giving birth (within 0-14 days), currently breastfeeding or planning to breastfeed, and have access to a refrigerator or freezer at home for storing samples. Participants will also need to be reachable by phone and have internet access. However, mothers with certain health conditions, those taking sleep aids, or whose newborns are in intensive care will not be eligible. If you join the study, you will provide samples for analysis, helping to contribute valuable information that could benefit future breastfeeding mothers and their babies.

Gender

FEMALE

Eligibility criteria

• 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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.