Stress and Breast Milk Study In the Neonatal Intensive Care Unit

NCT03617549 | Completed

• 1 other identifier: RSRB#000000
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Feeding; Breast Milk Expression; Stress

Keywords

neonatal intensive care

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

All Participants

Mothers of singleton moderate preterm appropriate for Gestational Age (AGA) infants (29-32+6 weeks gestation in the neonatal intensive care unit at the Golisano Children's Hospital

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mothers of singleton moderate preterm appropriate for Gestational Age (AGA) infants (29-32+6 weeks gestation29) will be approached during the enrollment period and screened for eligibility.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center NICU

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, saliva, breastmilk

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: June 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)