A Study of Melatonin Concentration During Lactation

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393296
• Other study ID #: 23-006493
• Status: Recruiting
• Start date: April 17, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Danielle Boos
• Phone: (715) 464-8173
• Email: boos.danielle[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study aims to learn more about promoting mothers' and babies' health by studying various maternal factors. Gaining a better understanding of the connections between a mother's emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mother's well-being.

Participants will be involved in the study during the immediate postpartum period. They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am. Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby, which may affect melatonin levels.

In addition to breast milk collection, participants will complete a series of questionnaires related to their emotion well-being and lifestyle. These questionnaires will help the research team understand how factors like stress, fatigue, depression, anxiety, sleep, and dietary patterns may be associated with melatonin and sIgA levels in breast milk. Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Eau Claire	Eau Claire	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Universidade Federal de Goias, University of Wisconsin, Eau Claire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melatonin concentration in breast milk	Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)	14 days postpartum
Primary	sIgA concentration in breast milk	concentration in breast milk samples, reported in picograms per milliliter (pg/mL)	14 days postpartum
Secondary	Anxiety Symptoms	Measured using the 14-item Depression, Anxiety and Stress Scale that assesses negative emotional states. Possible total scores range from 0 to 42, with higher scores indicating more negative emotional state and worse outcome.	14 days postpartum
Secondary	Depression Symptoms	Measured using the 10-item Edinburgh Depression Scale (EDS) that assesses depressive symptoms. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.	14 days postpartum
Secondary	Fatigue	Measured using the 10-item Fatigue Assessment Scale that assesses symptoms of chronic fatigue. Possible total scores range from 10 to 50. A total FAS score < 22 indicates no fatigue, a score = 22 indicates fatigue.	14 days postpartum
Secondary	Sleep Quality	Measured using the The Pittsburgh Sleep Quality Index that assesses the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.	14 days postpartum

External Links

•   Mayo Clinic Website