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Alteration of Stool Microbiota in Preterm Infants With Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554278
Recruitment Status : Suspended (Covid-19)
First Posted : June 13, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease
Anemia, Neonatal Necrotizing Enterocolitis Dysbiosis

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020


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



Primary Outcome Measures :
  1. qRT-PCR (polymerase chain reaction) quantitative stool analysis [ 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. ]
    Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples


Secondary Outcome Measures :
  1. Alpha diversity [ 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. ]
    Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples


Biospecimen Retention:   Samples Without DNA
Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554278


Locations
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United States, Texas
Parkland Health & Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Julie Mirpuri Hathiramani, MD UT Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:
Study Protocol  [PDF] November 22, 2017

Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03554278    
Other Study ID Numbers: STU 092017-028
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Texas Southwestern Medical Center:
NEC
transfusion
microbiome
premature
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Anemia
Anemia, Neonatal
Dysbiosis
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathologic Processes
Infant, Newborn, Diseases