Alteration of Stool Microbiota in Preterm Infants With Anemia

Study Overview
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Brief Summary
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This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

Detailed Description
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Necrotizing enterocolitis (NEC) is a leading cause of death in preterm infants, yet the disease mechanism is not well understood. Among the factors that have been studied are the change in stool microbiota (dysbiosis), severe anemia, and transfusion. Studies suggest that dysbiosis occurs in neonates with NEC. Large studies and meta-analyses have shown a predominance of Gammaproteobacteria, a decrease in Firmicutes, and decreased bacterial diversity in stool from infants with NEC. Studies do not support a relationship between transfusions and NEC since there are conflicting findings on this topic. There is a suggestion, however, that severe anemia may be associated with NEC though this requires further study. No studies have been done evaluating the relationship between anemia and change in stool microbiota, or blood transfusion and change in stool microbiota. This study aims to primarily evaluate the relationship between anemia and stool microbiota, and secondarily evaluate the relationship between transfusion and stool microbiota.

Official Title
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Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion

Conditions
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Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants less than 32 weeks gestation at birth Age at enrollment between 7 days and less than/equal to 30 days Minimum 100 mL/kg/day enteral feeds Exclusion Criteria: Development of necrotizing enterocolitis (NEC) prior to enrollment Prior surgery Major congenital anomalies Oxygen requirement with FiO2 (fraction of inspired oxygen) >50% (at time of enrollment)

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anemia<br>Stool samples from infants with anemia. Severe anemia defined as hematocrit less than 25%. Anemia defined as hematocrit greater than or equal to 25% and less than 30%. | |
| No Anemia<br>Stool samples from infants without anemia. No anemia defined as hematocrit equal to or greater than 30%. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qRT-PCR (polymerase chain reaction) quantitative stool analysis | Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples | qRT-PCR will be analyzed for infant stool samples from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha diversity | Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples | Infant stool samples will be analyzed from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NEC, transfusion, microbiome, premature