Alteration of Stool Microbiota in Preterm Infants With Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-09

Study Completion Date

2023-10-30

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.

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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.

Conditions

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Anemia, Neonatal Necrotizing Enterocolitis Dysbiosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anemia

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 interventions assigned to this group

No Anemia

Stool samples from infants without anemia. No anemia defined as hematocrit equal to or greater than 30%.

No interventions assigned to this group

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)

Minimum Eligible Age

7 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes