Stress and Breast Milk Study In the Neonatal Intensive Care Unit

Completed

• Conditions: Breast Feeding; Breast Milk Expression; Stress

• Registration Number: NCT03617549
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-06
• Study Start: 2019-06-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Rochester Medical Center NICU; 🇺🇸 Rochester, New York, United States