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NCT03617549 · ClinicalTrials.gov registry record
Stress and Breast Milk Study In the Neonatal Intensive Care Unit
A clinical trial, sponsored by University of Rochester.
- Completed
- Registry status
- 27
- Enrollment target
NCT03617549: Completed study, sponsored by University of Rochester.
NCT03617549 is a clinical trial that has completed, run by University of Rochester. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617549 has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-03-30 |
What the finished NCT03617549 record still lists
NCT03617549 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03617549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617549 about?
NCT03617549 is a clinical study titled "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 ma...
What is the current status of trial NCT03617549?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2019-06-01. Estimated completion is 2020-03-30.
Who is sponsoring clinical trial NCT03617549?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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