Understanding melatonin levels in breast milk during lactation
Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions
This study looks at how a new mother's feelings and daily habits affect melatonin levels in her breast milk to help improve health advice for moms and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Eau Claire, Wisconsin) |
| Trial ID | NCT06393296 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how a mother's emotional well-being and lifestyle factors, such as stress, fatigue, and sleep quality, influence melatonin and sIgA levels in breast milk. Participants, who are in the immediate postpartum period, will provide breast milk samples and complete questionnaires about their emotional and physical states. The study aims to uncover connections that could lead to improved health recommendations for mothers and their babies. Additionally, participants will use orange ambient light during nighttime infant care to minimize the impact of harsh lighting on melatonin levels.
Who should consider this trial
Good fit: Ideal candidates are mothers in the immediate postpartum period who are currently breastfeeding or planning to breastfeed.
Not a fit: Patients who have newborns with congenital malformations or those who are hospitalized in intensive care units may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for enhancing maternal and infant health through improved understanding of breast milk quality.
How similar studies have performed: While this study explores a specific aspect of maternal health, similar studies have shown promising results in understanding the impact of maternal factors on breast milk quality.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Eau Claire, Wisconsin
- Mayo Clinic Health System - Eau Claire — Eau Claire, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Ganesh Namachivayam, MD, MPH — Mayo Clinic
- Study coordinator: Danielle Boos
- Email: boos.danielle@mayo.edu
- Phone: (715) 464-8173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.