Clinical Trial

Maternal Stress on Human Milk and Infant Outcomes

Recruiting
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Summary
The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-03-26; most recent amendment 2025-05-16.
Status change: Not Yet Recruiting → Recruiting 2022-03-16
Trial Details
NCT Number NCT04821544
Lead Sponsor University of Idaho
Collaborators: Oregon State University, National Institute of General Medical Sciences (NIGMS), Kootenai Health
Conditions Postpartum Depression, Preterm Labor
Enrollment 500 participants
Start Date 2021-05-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-18