Alteration of Stool Microbiota in Preterm Infants With Anemia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03554278

Enrollment

Registered

2018-06-13

Start date

2018-10-09

Completion date

2023-10-30

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Neonatal, Dysbiosis, Necrotizing Enterocolitis

Keywords

NEC, transfusion, microbiome, premature

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Days to 30 Days

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
qRT-PCR (polymerase chain reaction) quantitative stool analysis	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.	Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples

Secondary

Measure	Time frame	Description
Alpha diversity	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.	Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples

Countries

United States

Outcome results