Anemia, NeonatalNCT03554278
Alteration of Stool Microbiota in Preterm Infants With Anemia
An observational study of Anemia, Neonatal and Necrotizing Enterocolitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health & Hospital System
Dallas, Texas, 75235
About this study
Official title: Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion
This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.
Read the 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.
- Conditions
- Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis
- Keywords
- NEC, transfusion, microbiome, premature
- Medical subject headings
- Anemia, Neonatal, Enterocolitis, Necrotizing, Dysbiosis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
qRT-PCR (polymerase chain reaction) quantitative stool analysis
Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples
Measured: 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
Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start9 Oct 2018
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anemia, NeonatalStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Mirpuri Hathiramani, University of Texas Southwestern Medical Center
- Investigators
- Julie Mirpuri Hathiramani, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554278
- Sponsor's protocol ID
- STU 092017-028
- Status last verified
- Feb 2025
- First submitted
- 3 May 2018
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25798435Patel 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.
PubMed 25992911Warner 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.
PubMed 27343151Warner 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.
PubMed 26969089Zhou 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.
PubMed 25741698Pammi 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.
PubMed 28274256Patel 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.
PubMed 26934258Hay 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.
PubMed 27866662
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion
- ClinicalTrials.gov ID
- NCT03554278
- Acronym / sponsor ID
- STU 092017-028
- Conditions
- Anemia, Neonatal, Necrotizing Enterocolitis, Dysbiosis
- Keywords
- NEC, transfusion, microbiome, premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 7 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 25798435Gritz 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.
- Background: PubMed 25992911Patel 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.
- Background: PubMed 27343151Warner 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.
- Background: PubMed 26969089Warner 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.
- Background: PubMed 25741698Zhou 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.
- Background: PubMed 28274256Pammi 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.
- Background: PubMed 26934258Patel 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.
- Background: PubMed 27866662Hay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Mirpuri Hathiramani, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Neonatal and Necrotizing Enterocolitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554278, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.