PrematurityNCT05537454
Maternal Stress, Milk Composition, and Preterm Neurodevelopment
An observational study of Prematurity, run by University of Minnesota at 1 site in United States.
Trial summary
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age. Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Prematurity
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2022to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Early preterm infants and their mothers
Who may be able to join
- preterm infant born between 25 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
- mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery
Who cannot join
- infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
- mothers: known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Emily Nagel, PhD, 612-624-9222, NICUSTRESSstudy@umn.du
About this study
Official title: Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
Read the detailed description
The proposed study will address our novel hypothesis that maternal stress is associated with feeding outcomes and markers of impaired neurodevelopment for preterm infants and alters human milk and infant gut profiles in ways that affect preterm neurodevelopment.
Mothers and their preterm infants (28-34 weeks gestation at birth) will be recruited to determine if: (1) variation in postnatal stress among mothers of very preterm infants relates to the total volume or proportion of maternal milk provided to her infant in the NICU and if (2) variation in maternal postnatal stress relates to her preterm infant's neurocognitive status at NICU discharge and 4 months corrected age. This project also involves collection/storage of maternal milk and infant fecal samples for multi-omics analyses. More specifically, the study will address: (3A) Is maternal postnatal stress associated with the metabolomic and microbiome characteristics of the infant's gut and/or the milk composition?, and (3B) Do milk composition differences relate to infant neurodevelopment? The aims of the proposed study contribute to our overarching research goal, which is to improve neurodevelopmental health for preterm infants by building the health and resilience of the mother-milk-infant triad.
- Conditions
- Prematurity
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal milk production inpatient
total volume (mL)
Measured: 28-35 weeks postmenstrual age
Maternal milk production 4 months corrected age
total volume (mL)
Measured: 4 months corrected age
Maternal milk proportion inpatient
Proportion of maternal milk vs donor milk/formula (%)
Measured: 28-35 weeks postmenstrual age
Maternal milk proportion 4 months corrected age
Proportion of maternal milk vs donor milk/formula (%)
Measured: 4 months corrected age
Infant Neurodevelopment inpatient
event related potentials (ERP)
Measured: 35-37 weeks postmenstrual age
Infant Neurodevelopment 4 months corrected age
event related potentials (ERP)
Measured: 4 months corrected age
Infant Neurodevelopment 4 months corrected age
visual evoked potentials (VEP)
Measured: 4 months corrected age
Infant gut microbiome inpatient
Microbial diversity of fecal samples
Measured: 28-35 weeks postmenstrual age
Milk microbiome inpatient
Microbial diversity of milk samples
Measured: 28-35 weeks postmenstrual age
Milk microbiome 4 months corrected age
Microbial diversity of milk samples
Measured: 4 months corrected age
Milk metabolome inpatient
Concentration of untargeted and targeted metabolites
Measured: 28-35 weeks postmenstrual age
Milk metabolome 4 months corrected age
Concentration of untargeted and targeted metabolites
Measured: 4 months corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start9 Dec 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537454
- Sponsor's protocol ID
- SPH-2022-31233
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data upon request
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes
- ClinicalTrials.gov ID
- NCT05537454
- Acronym / sponsor ID
- SPH-2022-31233
- Conditions
- Prematurity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 13 Sep 2022 (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.
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
Detailed description
The proposed study will address our novel hypothesis that maternal stress is associated with feeding outcomes and markers of impaired neurodevelopment for preterm infants and alters human milk and infant gut profiles in ways that affect preterm neurodevelopment.
Mothers and their preterm infants (28-34 weeks gestation at birth) will be recruited to determine if: (1) variation in postnatal stress among mothers of very preterm infants relates to the total volume or proportion of maternal milk provided to her infant in the NICU and if (2) variation in maternal postnatal stress relates to her preterm infant's neurocognitive status at NICU discharge and 4 months corrected age. This project also involves collection/storage of maternal milk and infant fecal samples for multi-omics analyses. More specifically, the study will address: (3A) Is maternal postnatal stress associated with the metabolomic and microbiome characteristics of the infant's gut and/or the milk composition?, and (3B) Do milk composition differences relate to infant neurodevelopment? The aims of the proposed study contribute to our overarching research goal, which is to improve neurodevelopmental health for preterm infants by building the health and resilience of the mother-milk-infant triad.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Early preterm infants and their mothers
Key inclusion criteria (2 listed)
- preterm infant born between 25 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
- mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery
Key exclusion criteria (2 listed)
- infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
- mothers: known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
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
Maternal milk production inpatient
Time frame: 28-35 weeks postmenstrual age
total volume (mL)
Maternal milk production 4 months corrected age
Time frame: 4 months corrected age
total volume (mL)
Maternal milk proportion inpatient
Time frame: 28-35 weeks postmenstrual age
Proportion of maternal milk vs donor milk/formula (%)
Maternal milk proportion 4 months corrected age
Time frame: 4 months corrected age
Proportion of maternal milk vs donor milk/formula (%)
Infant Neurodevelopment inpatient
Time frame: 35-37 weeks postmenstrual age
event related potentials (ERP)
Infant Neurodevelopment 4 months corrected age
Time frame: 4 months corrected age
event related potentials (ERP)
Infant Neurodevelopment 4 months corrected age
Time frame: 4 months corrected age
visual evoked potentials (VEP)
Infant gut microbiome inpatient
Time frame: 28-35 weeks postmenstrual age
Microbial diversity of fecal samples
Milk microbiome inpatient
Time frame: 28-35 weeks postmenstrual age
Microbial diversity of milk samples
Milk microbiome 4 months corrected age
Time frame: 4 months corrected age
Microbial diversity of milk samples
Milk metabolome inpatient
Time frame: 28-35 weeks postmenstrual age
Concentration of untargeted and targeted metabolites
Milk metabolome 4 months corrected age
Time frame: 4 months corrected gestational age
Concentration of untargeted and targeted metabolites
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified data upon request
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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.
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 Prematurity, run by University of Minnesota 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Nagel, PhD, RD (612-624-9222, NICUSTRESSstudy@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal milk production inpatient (time frame: 28-35 weeks postmenstrual age). The study lists 12 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 14 Sep 2026.