Stress and Breast Milk Study In the Neonatal Intensive Care Unit

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617549
• Other study ID #: RSRB#000000
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Breast Milk Expression
• Stress

Locations

Country	Name	City	State
United States	University of Rochester Medical Center NICU	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between secretory IgA levels in mother's serum and reported stress	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.	baseline
Primary	Correlation between secretory IgA levels in mother's serum and reported stress	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.	1 month