Stress and Breast Milk Study In the Neonatal Intensive Care Unit (NCT03617549) | Clinical Trial Compass
CompletedNot Applicable
Stress and Breast Milk Study In the Neonatal Intensive Care Unit
United States27 participantsStarted 2019-06-01
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between secretory IgA levels in mother's serum and reported stress
Timeframe: baseline
2
Correlation between secretory IgA levels in mother's serum and reported stress