An observational study in Anemia, Neonatal, Necrotizing Enterocolitis and Dysbiosis, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 7 Days to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by University of Texas Southwestern Medical Center · Observational
This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 57 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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The study will enroll preterm infants that are less than 32 weeks gestational age at birth. At time of enrollment, these infants must be between 7 days of age up to (and including) 30 days of age. They must also be on enteral feeds of at least 100mL/kg/day. The investigators will exclude infants who have developed NEC prior to enrollment, who have had surgery prior to enrollment, who have major congenital anomalies, or who are requiring FiO2 >50% at time of enrollment.
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Exclusion Criteria:
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%.
Stool samples from infants without anemia. No anemia defined as hematocrit equal to or greater than 30%.
qRT-PCR (polymerase chain reaction) quantitative stool analysis
Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples
Time frame: 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.
Alpha diversity
Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples
Time frame: 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.
Plan to share: No
Ran from Oct 2018 to primary completion in Oct 2023, 60 months.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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