Stress and Breast Milk Study In the Neonatal Intensive Care Unit

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03617549

Enrollment

Registered

2018-08-06

Start date

2019-06-01

Completion date

2020-03-30

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Breast Milk Expression, Stress

Keywords

neonatal intensive care

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results