Alteration of Stool Microbiota in Preterm Infants With Anemia

NCT03554278 | Completed

• 1 other identifier: STU 092017-028
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Neonatal; Necrotizing Enterocolitis; Dysbiosis

Keywords

NEC; transfusion; microbiome; premature

Outcome Measures

Primary Outcomes (1)

• qRT-PCR (polymerase chain reaction) quantitative stool analysis

  Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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%.

Eligibility Criteria

• Age: 7 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (8)

• Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015.

  PMID: 25798435 BACKGROUND

• Patel RM, Denning PW. Intestinal microbiota and its relationship with necrotizing enterocolitis. Pediatr Res. 2015 Sep;78(3):232-8. doi: 10.1038/pr.2015.97. Epub 2015 May 20.

  PMID: 25992911 BACKGROUND

• Warner BB, Tarr PI. Necrotizing enterocolitis and preterm infant gut bacteria. Semin Fetal Neonatal Med. 2016 Dec;21(6):394-399. doi: 10.1016/j.siny.2016.06.001. Epub 2016 Jun 22.

  PMID: 27343151 BACKGROUND

• Warner BB, Deych E, Zhou Y, Hall-Moore C, Weinstock GM, Sodergren E, Shaikh N, Hoffmann JA, Linneman LA, Hamvas A, Khanna G, Rouggly-Nickless LC, Ndao IM, Shands BA, Escobedo M, Sullivan JE, Radmacher PG, Shannon WD, Tarr PI. Gut bacteria dysbiosis and necrotising enterocolitis in very low birthweight infants: a prospective case-control study. Lancet. 2016 May 7;387(10031):1928-36. doi: 10.1016/S0140-6736(16)00081-7. Epub 2016 Mar 9.

  PMID: 26969089 BACKGROUND

• Zhou Y, Shan G, Sodergren E, Weinstock G, Walker WA, Gregory KE. Longitudinal analysis of the premature infant intestinal microbiome prior to necrotizing enterocolitis: a case-control study. PLoS One. 2015 Mar 5;10(3):e0118632. doi: 10.1371/journal.pone.0118632. eCollection 2015.

  PMID: 25741698 BACKGROUND

• Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8.

  PMID: 28274256 BACKGROUND

• Patel RM, Knezevic A, Shenvi N, Hinkes M, Keene S, Roback JD, Easley KA, Josephson CD. Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis in Very Low-Birth-Weight Infants. JAMA. 2016 Mar 1;315(9):889-97. doi: 10.1001/jama.2016.1204.

  PMID: 26934258 BACKGROUND

• Hay S, Zupancic JA, Flannery DD, Kirpalani H, Dukhovny D. Should we believe in transfusion-associated enterocolitis? Applying a GRADE to the literature. Semin Perinatol. 2017 Feb;41(1):80-91. doi: 10.1053/j.semperi.2016.09.021. Epub 2016 Nov 17.

  PMID: 27866662 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Anemia, Neonatal; Enterocolitis, Necrotizing; Dysbiosis; Premature Birth

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Julie Mirpuri Hathiramani, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 13, 2018
• Study Start: October 9, 2018
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)