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Clinical Trials/NCT03617549
NCT03617549
Completed
Not Applicable

A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants

University of Rochester1 site in 1 country27 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Feeding
Sponsor
University of Rochester
Enrollment
27
Locations
1
Primary Endpoint
Correlation between secretory IgA levels in mother's serum and reported stress
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
March 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Casey Rosen-Carole

Assistant Professor

University of Rochester

Eligibility Criteria

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

Outcomes

Primary Outcomes

Correlation between secretory IgA levels in mother's serum and reported stress

Time Frame: 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.

Study Sites (1)

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