Dallas, Texas 75235

  • Dysbiosis

Purpose:

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


Study summary:

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.


Criteria:

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)


NCT ID:

NCT03554278


Primary Contact:

Principal Investigator
Julie Mirpuri Hathiramani, MD
UT Southwestern Medical Center

Julie Mirpuri, MD
Phone: 214-648-0454
Email: Julie.Mirpuri@UTSouthwestern.edu


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75235
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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