Dynamics of the Microbiome in the Premature Infant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- antigen identification of the infant microbiome over the first year of life
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Hour to 1 Week (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •infants with genetic diseases or gross anomalies
- •parents who are not willing to give consent
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported