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Stress and Breast Milk Study In the Neonatal Intensive Care Unit

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT03617549
Collaborator
(none)
27
Enrollment
1
Location
10
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of this research is to clarify the relationship between reported maternal stress, biological measures of maternal stress, breast milk biomarkers and milk quantity. Our primary hypothesis is that measures of maternal stress are associated with cortisol, cytokines, and other stress markers in the blood, which impacts breast milk quantity and composition and which may impact infant health.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    27 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants
    Actual Study Start Date :
    Jun 1, 2019
    Actual Primary Completion Date :
    Mar 30, 2020
    Actual Study Completion Date :
    Mar 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    All Participants

    Mothers of singleton moderate preterm appropriate for Gestational Age (AGA) infants (29-32+6 weeks gestation in the neonatal intensive care unit at the Golisano Children's Hospital

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between secretory IgA levels in mother's serum and reported stress [baseline]

      Mother's stress will be measured using the The Parent Stress Scale: Neonatal Intensive Care Unit. This scale ranges from 1-130 with higher numbers indicating more stress. Serum will be collected from mothers at enrollment and 4 weeks postpartum. Maternal venipuncture will be used to collect an 0.5mL aliquot of whole blood at the time of mother's first morning pump session in the neonatal intensive care unit. IgA will be quantitated using the Millipore Magpix 100 System. Multivariate regression analysis will be used to test for correlations.

    2. Correlation between secretory IgA levels in mother's serum and reported stress [1 month]

      Mother's stress will be measured using the The Parent Stress Scale: Neonatal Intensive Care Unit. This scale ranges from 1-130 with higher numbers indicating more stress. Serum will be collected from mothers at enrollment and 4 weeks postpartum. Maternal venipuncture will be used to collect an 0.5mL aliquot of whole blood at the time of mother's first morning pump session in the neonatal intensive care unit. IgA will be quantitated using the Millipore Magpix 100 System. Multivariate regression analysis will be used to test for correlations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    • Baby will remain in mom's legal custody

    • Intends to exclusively breastfeed during the NICU stay

    • Has kept a daily log of milk expression (pump or hand expression) with date/time/quantity since birth of their child

    • Less than 7 days postpartum

    Exclusion Criteria:

    • Baby and mother are to be separated due to legal custody issues

    • Medical contraindication to breastfeeding

    • Non-English speaking

    • Unable to answer a written survey in English

    • More than 50% of infant intake is not mother's own milk at 4 weeks postpartum

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center NICU Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Casey Rosen-Carole, Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT03617549
    Other Study ID Numbers:
    • RSRB#000000
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Aug 3, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Casey Rosen-Carole, Assistant Professor, University of Rochester
    neonatal intensive care

    Study Results

    No Results Posted as of Aug 3, 2020