Stress and Breast Milk Study In the Neonatal Intensive Care Unit

NCT ID: NCT03617549

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-03-30

Brief Summary

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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

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Conditions

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Breast Feeding Breast Milk Expression Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Casey Rosen-Carole

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center NICU

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSRB#000000

Identifier Type: -

Identifier Source: org_study_id

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