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Maternale stress op de resultaten van moedermelk en zuigelingen

5 november 2026 bijgewerkt door: Yimin Chen, University of Idaho

Effecten van maternale stress op de samenstelling van moedermelk en de daaropvolgende baby-uitkomsten

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

During every two-week period, newly admitted infants (both preterm <37 weeks gestational age and term ≥37 weeks gestational age) at performance site Kootenai Health NICU and term infants from the Palouse region will be block randomized to control (standard of care), mindfulness intervention (modified 8-week mindfulness

-based intervention (with a focus on self-compassion; MBSC), or vitamin D supplementation (8-week 2,000 IU vitamin D3 supplementation) groups. The purpose of the nested cohorts is to minimize the postpartum time difference among cohort mothers. Each nested MBSC cohort will undergo the 8-week MBSC intervention with a focus on increasing self-compassion. The MBSC program includes previously developed daily mindfulness practices, guided meditations, routine mindfulness prompts, and four video conference group sessions with a certified mindfulness facilitator.

Maternal data: The Perceived Stress Scale (PSS) and Self-Compassion Scale-Short Form (SCS-SF) will be given to mothers from both groups pre- and post-intervention, and during the 4th week. Saliva, urine, stool, and human milk samples will be collected at the same time points as above. Additional maternal data include: age, race, height, weight (pre-pregnancy and last weight before delivery), parity, delivery mode, chorioamnionitis, preeclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelet) syndrome, antenatal antibiotics, anti-depressants or other mood-altering/neurochemical medications (current and during pregnancy), diagnosis of depression or other mental illness within the previous 5 years, history of postpartum depression and postpartum psychosis, diabetes, hypertension, heart disease, and any inflammatory or autoimmune diseases.

Infant data: Gestational age, birth weight, ventilation requirement, surgical interventions, patent ductus arteriosus, growth, nutrition prescriptions, saliva, urine and stool samples.

Data collection: All data (not including biosamples) will be collected using REDCap hosted within the UI system.

Sample measurements: Maternal salivary cortisol (marker of stress) and oxytocin (marker of anxiety and "social-closeness") concentrations will be measured using ELISA. Human milk proteins will be identified using mass spectrometry-based proteomics. Following proteomic analyses, targeted proteins will be quantified using ELISA and Western Blot. Both maternal and infant saliva, urine and stool samples will be used for metabolomic and transcriptomic sequencing to identify metabolic and molecular changes, respectively, in both mothers and infants. Infant systemic oxidative stress will be measured through urine F2-isoprostanes concentrations (ELISA), and infant intestinal inflammation will be determined with stool calprotectin concentrations (ELISA).

Studietype

Ingrijpend

Inschrijving (Geschat)

500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Idaho
      • Coeur d'Alene, Idaho, Verenigde Staten, 83814
        • Werving
        • Kootenai Health
        • Contact:
          • Brook Lang, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Mothers of newborn infants at Kootenai Health NICU and the Palouse region

Exclusion Criteria:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control

Control group will receive link to a free 8-week Mindfulness Based Stress Reduction intervention AFTER the 8-weel trial period. This group will also receive placebo gummies that appear the same as the vitamin D gummies.
Experimenteel: Mindfulness-based intervention (with a focus on self-compassion; MBSC)

8-week MBSC intervention with a focus on increasing self-compassion. The MBSC program includes previously developed daily mindfulness practices, guided meditations, routine mindfulness prompts, and four video conference group sessions with a certified mindfulness facilitator.
Gedragsmatig: Mindfulness-based intervention (with a focus on self-compassion; MBSC)

8-week MBSC intervention with a focus on increasing self-compassion
Experimenteel: Vitamin D

Vitamin D gummies of 2,000 IU/day for 8 weeks.
Voedingssupplement: Vitamin D

Vitamin D at 2,000 IU/day for 8 weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maternal Stress - Biomarker Change
Tijdsspanne: Baseline to 4 and 8 weeks

Salivary cortisol - Change from Baseline cortisol to 4 and 8 weeks
Baseline to 4 and 8 weeks
Maternal Stress - Psychometric Measure Change
Tijdsspanne: Baseline to 4 and 8 weeks

Perceived Stress Scale (PSS) - Change from Baseline PSS to 4 and 8 weeks

The Perceived Stress Scale (PSS) is validated and the most widely used instrument to measure perception of stress. The PSS includes 14 questions inquiring about feelings and thoughts during the past month expressed through frequency. The PSS will be used pre-intervention, post-intervention (8 weeks), and at the mid-point of the intervention (4 weeks). The scale for each question ranges from 0-4. The PSS measures how often the responder found life to be unpredictable, uncontrollable, and overloaded. Higher score indicates higher perceived stress. The total score ranges between 0-56.
Baseline to 4 and 8 weeks
Maternal Self-compassion - Biomarker Change
Tijdsspanne: Baseline to 4 and 8 weeks

Salivary oxytocin - Change from Baseline oxytocin to 4 and 8 weeks
Baseline to 4 and 8 weeks
Maternal Self-compassion - Psychometric Measure Change
Tijdsspanne: Baseline to 4 and 8 weeks

Self-Compassion Scale-Short Form (SCS-SF) - Change from Baseline SCS-SF to 4 and 8 weeks

The Self-Compassion Scale-Short Form (SCS-SF)19 is a shortened and highly correlated (r ≥ 0.97) scale (12 items) from the original 26-item SCS. The SCS-SF measures six key components of self-compassion using a scale that ranges from 1-5: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identification. Self-compassion is associated with psychological well-being and is therefore often measured alongside stress and anxiety. High score indicates higher self-compassion. The total score ranges between 0-60.
Baseline to 4 and 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Human Milk Proteins & Peptides Change
Tijdsspanne: Baseline to 4 and 8 weeks

Protein and peptide profiles will be measured using proteomic & peptidomic analyses to assess human milk protein and peptide changes from baseline to 4 and 8 weeks as a function of maternal changes in stress/self-compassion. These are measured outcomes.
Baseline to 4 and 8 weeks
Maternal Metabolomic & Transcriptomic Changes
Tijdsspanne: Baseline to 4 and 8 weeks

Maternal metabolomic pathways & gene activation changes from baseline to 4 and 8 weeks in response to changes in stress/self-compassion. These are measured outcomes.
Baseline to 4 and 8 weeks
Infant Metabolomic & Transcriptomic Changes
Tijdsspanne: Baseline to 4 and 8 weeks

Infant metabolomic pathways & gene activation changes from baseline to 4 and 8 weeks in response to maternal changes in stress/self-compassion, and human milk protein/peptide profile changes. These are measured outcomes.
Baseline to 4 and 8 weeks
Maternal Vitamin D Changes
Tijdsspanne: Baseline to 4 and 8 weeks

Maternal vitamin D status changes in both serum and human milk from baseline to 4 and 8 weeks.
Baseline to 4 and 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Idaho

Medewerkers

National Institute of General Medical Sciences (NIGMS)
Oregon State University
Kootenai Health

Onderzoekers

  • Hoofdonderzoeker: Yimin Chen, PhD, University of Idaho

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2021

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

17 november 2020

Eerst ingediend dat voldeed aan de QC-criteria

26 maart 2021

Eerst geplaatst (Werkelijk)

29 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20-024
  • 5U54GM104944-08 (Subsidie/contract van de Amerikaanse NIH)
  • P20GM152304 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

IPD will be available upon request.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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