Breast FeedingNCT03617549
Stress and Breast Milk Study In the Neonatal Intensive Care Unit
An observational study of Breast Feeding and Breast Milk Expression, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Feeding, Breast Milk Expression, Stress
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center NICU
Rochester, New York, 14642
About this study
Official title: A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants
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
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jun 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casey Rosen-Carole, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617549
- Sponsor's protocol ID
- RSRB#000000
- Status last verified
- Jul 2020
- First submitted
- 1 Aug 2018
- Last updated
- 3 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants
- ClinicalTrials.gov ID
- NCT03617549
- Acronym / sponsor ID
- RSRB#000000
- Conditions
- Breast Feeding, Breast Milk Expression, Stress
- Keywords
- neonatal intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding and Breast Milk Expression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between secretory IgA levels in mother's serum and reported stress (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.