A Study of Melatonin Concentration During Lactation
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.
Conditions:
🦠 Breastfeeding
🗓️ Study Start (Actual) 17 April 2024
🗓️ Primary Completion (Estimated) 30 November 2024
✅ Study Completion (Estimated) 30 November 2024
👥 Enrollment (Estimated) 120
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Eau Claire, Wisconsin, United States

📋 Eligibility Criteria

Description

    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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 April 2024
  • First Submitted that Met QC Criteria 26 April 2024
  • First Posted 1 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 April 2024
  • Last Update Posted 1 May 2024
  • Last Verified April 2024