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Completed

NCT Number: NCT03617549

Stress and Breast Milk Study In the Neonatal Intensive Care Unit

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.

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Key information

Conditions

Breast Feeding Behavior Breast Milk Expression Feeding Behavior Stress

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester Medical Center NICU

Rochester, New York, 14642, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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