Mindfulness and meditation lactation education for mothers of premature NICU infants
Official title: The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study
Run by Mayo Clinic · NCT07351799 · Data updated 2026-11-12
This will test whether mindfulness and meditation training for mothers who are pumping for their premature NICU infants changes components of their breastmilk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | November 2, 2026 |
| Study ends | November 2, 2026 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07351799 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking mothers over age 20 who delivered a singleton infant at <34 0/7 weeks at Mayo Clinic Rochester, are enrolled within 72 hours of birth, have an infant admitted to the NICU, and are pumping at least eight times per 24 hours.
✕Probably not a fit
Mothers with extensive prior mindfulness practice, a history of breast/chest surgery, PCOS, current illicit substance abuse, severe active psychiatric conditions, or those who delivered multiples are unlikely to qualify or receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls mothers within 72 hours of delivery whose infants (gestational age <34 0/7 weeks) are admitted to the NICU at Mayo Clinic Rochester. Eligible participants who pump at least eight times per 24 hours will receive either standard lactation care or additional mindfulness- and meditation-based education. Researchers will collect pumped breastmilk and analyze changes in milk composition and related biomarkers over the intervention period while tracking maternal stress and lactation behaviors. The protocol excludes mothers with extensive prior mindfulness practice, certain medical or psychiatric conditions, and multiple gestations.
Why it matters
Potential benefit: If successful, the intervention could improve breastmilk composition or lactation outcomes for mothers of preterm infants, potentially supporting neonatal nutrition and recovery.
How similar studies have gone: Prior studies indicate mindfulness can reduce maternal stress and improve breastfeeding behaviors, but effects on breastmilk composition in NICU mothers are largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age \> 20 years of age * Read, write and understand English * Infant NICU admit * Infant birthplace of Rochester, MN (Mayo Clinic) * Maternal adherence to pumping ≥ 8 times in 24 hours * Mother enrolled within 72 hours of birth * Gestational age of neonate at birth of \< 34 0/7 weeks Exclusion Criteria: * Maternal extensive existing mindfulness practice * Maternal breast/chest surgery * Maternal polycystic ovarian syndrome (PCOS) * Maternal current illicit substance abuse * Diagnosis of maternal current severe mental health concerns * Maternal multiple gestation (twins or higher order) pregnancy and delivery
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Ashley Thompson — Mayo Clinic
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Think Tank nutritional drink to help thinking after stress in middle-aged women.
This trial will test whether taking the 'Think Tank' nutritional drink helps thinking and mood after a physical and psychological stressor in healthy women aged 40–60 who drink caffeine daily.
-
Recovering Together After Cardiac Arrest: a mind-body resilience program for survivors and caregivers.
This project will try two brief mind-body programs to help cardiac arrest survivors and their caregivers reduce anxiety, depression, and emotional distress.
-
Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges
This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.
-
Tele-based wellbeing centres for women's mental health in Bangladesh
A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Focused ultrasound for mood and anxiety disorders
This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.