Dynamics of the Microbiome in the Premature Infant
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 12, 2024
June 1, 2016
2.2 years
April 21, 2014
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
12 months
Study Arms (1)
very low birth weight infants
Very low birth weight infants weighing 1500 grams at birth or less
Eligibility Criteria
Very low birth weight infants
You may qualify if:
- grams or less at birth
- infants without genetic diseases or gross anomalies
- mother has to be planning on providing breast milk to the infant
You may not qualify if:
- infants with genetic diseases or gross anomalies
- parents who are not willing to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Hospital
Durham, North Carolina, 27701, United States
Biospecimen
Blood, stool, serum, breastmilk
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Seed, MD PhD
Duke Univeristy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2014
First Posted
April 24, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
April 12, 2024
Record last verified: 2016-06