Dynamics of the Microbiome in the Premature Infant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dynamics of the Microbiome in the Premature Infant

Conditions
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Infection

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| very low birth weight infants<br>Very low birth weight infants weighing 1500 grams at birth or less | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very Low Birth Weight (VLBW), Microbiome