ACTIVE_NOT_RECRUITING

A Study of Melatonin Concentration During Lactation

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Conditions

Breastfeeding

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions

Quick Facts

Study Start:2024-04-17
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06393296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Possess a refrigerator with a freezer or a standalone freezer for sample storage at home.
  2. * Ability to be contacted by telephone.
  3. * Having internet access at home.
  4. * Being in the immediate (0-14 days) postpartum period.
  5. * Currently breastfeeding or planning to breastfeed, regardless of the type.
  1. * Newborns with congenital malformations.
  2. * Newborns with birth weights less than 2,500g or greater than 4,000g.
  3. * Gestational age less than 37 completed weeks or greater than 42 completed weeks.
  4. * Mothers hospitalized in an intensive care unit (ICU).
  5. * Newborns hospitalized in the neonatal intensive care unit (NICU) or special care nursery (SCN).
  6. * Mothers using sleep aids (e.g., Benadryl, Unisom, Melatonin, Valerian).
  7. * Mothers currently being treated for pharmacologically treated mood and sleep disorders.
  8. * 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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.

Contacts and Locations

Principal Investigator

Ganesh Namachivayam, MD, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Ganesh Namachivayam, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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

Study Start Date2024-04-17
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2026-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breastfeeding