InfectionNCT02121938
Dynamics of the Microbiome in the Premature Infant
An observational study of Infection, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes. Read more about this study
- Who is it for?
- Ages 1 hour to 1 week
- Conditions the study is for
- Infection
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2016
- 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 1 hour to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: Very low birth weight infants
Who may be able to join
- 1500 grams or less at birth
- infants without genetic diseases or gross anomalies
- mother has to be planning on providing breast milk to the infant
Who cannot join
- infants with genetic diseases or gross anomalies
- parents who are not willing to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27701
About this study
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.
Read the detailed description
The study team will collect samples of blood and stool from preterm infants once a week from the first week of life until 8 weeks after delivery. Blood samples will be collected from left over blood that is being collected for clinical management. No extra blood draws will be done for research purposes only. Samples of leftover breast milk will be collected once weekly from the first week of life until 8 weeks after delivery.
While the baby is in the hospital the study team will collect information about the growth and development as well as events that happen during their intensive care nursery (ICN) hospitalization.
In addition, blood and stool will be collected, as well as information about the growth when the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6 and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be done at the same time that labs for clinical management are being done.
A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected after delivery. Information will also be collected from the medical record.
- Conditions
- Infection
- Keywords
- Very Low Birth Weight (VLBW), Microbiome
- Medical subject headings
- Infections
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 |
|---|---|---|
| very low birth weight infants | Very low birth weight infants weighing 1500 grams at birth or less |
What is being measured
The primary outcome is the main question the study is designed to answer.
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 1
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 2
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 3
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 4
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 5
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 6
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 7
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: Week 8
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: 6 months
antigen identification of the infant microbiome over the first year of life
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Seed, MD PhD, Principal investigator, Duke Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121938
- Sponsor's protocol ID
- Pro00051659
- Status last verified
- Jun 2016
- First submitted
- 21 Apr 2014
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of the Microbiome in the Premature Infant
- ClinicalTrials.gov ID
- NCT02121938
- Acronym / sponsor ID
- Pro00051659
- Conditions
- Infection
- Keywords
- Very Low Birth Weight (VLBW), Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Apr 2014 (estimated)
- 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 purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.
Detailed description
The study team will collect samples of blood and stool from preterm infants once a week from the first week of life until 8 weeks after delivery. Blood samples will be collected from left over blood that is being collected for clinical management. No extra blood draws will be done for research purposes only. Samples of leftover breast milk will be collected once weekly from the first week of life until 8 weeks after delivery.
While the baby is in the hospital the study team will collect information about the growth and development as well as events that happen during their intensive care nursery (ICN) hospitalization.
In addition, blood and stool will be collected, as well as information about the growth when the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6 and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be done at the same time that labs for clinical management are being done.
A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected after delivery. Information will also be collected from the medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| very low birth weight infants | – | –Very low birth weight infants weighing 1500 grams at birth or less |
Who may qualify
- Ages
- 1 hour to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very low birth weight infants
Key inclusion criteria (3 listed)
- 1500 grams or less at birth
- infants without genetic diseases or gross anomalies
- mother has to be planning on providing breast milk to the infant
Key exclusion criteria (2 listed)
- infants with genetic diseases or gross anomalies
- parents who are not willing to give consent
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
antigen identification of the infant microbiome over the first year of life
Time frame: Week 1
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 2
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 3
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 4
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 5
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 6
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 7
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: Week 8
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: 6 months
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
antigen identification of the infant microbiome over the first year of life
Time frame: 12 months
The investigators immediate goal is to identify antigens of the preterm infant microbiome that are recognized by natural and adaptive antibodies and determine how mucosal and serologic antibody responses alter the dynamics of secondary intestinal colonization.
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 12 Apr 2024.
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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. This study is not recruiting at the moment.
Patrick Seed, MD PhD principal investigator
Duke Univeristy
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 Infection, run by Duke University 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 3 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: finished, as of the sponsor's last update on 12 Apr 2024. 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?
antigen identification of the infant microbiome over the first year of life (time frame: Week 1). The study lists 10 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 12 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.