Mindfulness and meditation lactation education for mothers of premature NICU infants
The Impact of Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU: Intervention Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07351799 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior studies indicate mindfulness can reduce maternal stress and improve breastfeeding behaviors, but effects on breastmilk composition in NICU mothers are largely untested.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Thompson — Mayo Clinic
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.