NCT02741648

Brief Summary

The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that may lead to a better understanding of what makes an ELBW infant at risk for digestive tract problems such as necrotizing enterocolitis.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

9.7 years

First QC Date

April 13, 2016

Last Update Submit

February 4, 2026

Conditions

AnemiaNecrotizing Enterocolitis

Keywords

Red Blood Cell TransfusionDigestive tract problemsExtremely Low Birth Weight

Outcome Measures

Primary Outcomes (8)

  • Mesenteric Tissue Oxygenation

    Mesenteric tissue oxygenation is measured in infants receiving RBC transfusion. Mesenteric regional saturation of oxygen (MES-rSO2) levels are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring. MES-rSO2 will be compared between infants receiving RBC transfusion with and without IST.

    60 Minutes prior to transfusion to 48 hours after transfusion

  • Infants Developing TR-NEC

    Development of TR-NEC will be compared between infants receiving RBC transfusion with and without IST.

    60 Minutes prior to transfusion to 48 hours after transfusion

  • Inhibition of NO-Mediated Vasodilation

    Inhibition of NO-mediated vasodilation will be used to assess RBC function among transfused infants who develop TR-NEC and matched control infants who do not develop TR-NEC.

    60 Minutes prior to transfusion to 48 hours after transfusion

  • Metabolic Changes of Red Blood Cells

    Functional defects of transfused RBCs will be examined to assess metabolic changes of RBCs among transfused infants who develop TR-NEC and matched control infants who do not develop TR-NEC.

    60 Minutes prior to transfusion to 48 hours after transfusion

  • Mesenteric Tissue Oxygenation During the NEC Window Period

    ELBW infants that reach the window when NEC typically occurs will be further compared as those with vs without anemia. Regional Oxygenation Saturation Levels (rSO2) are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring. NIRS will be performed once per week (whether transfused or not) for a 48 hour period starting each Monday (day of routine lab draw to evaluate anemia).

    28 to 34 Weeks Post Menstrual Age

  • Immune Cell Function

    Anemia significantly modulates immune function and may predispose infants to NEC through alterations in T cell activation and the presence of immunomodulatory erythroid precursors. Immune cell function profiles will be compared between infants who develop TR-NEC and matched controls who do not.

    Up to 90 days of age

  • Microbial Changes

    Alterations in the microbiota may further drive dysregulated immune function toward increased overall inflammation and the development of NEC. Microbial profiles will be compared between infants who develop TR-NEC and matched controls who do not.

    Up to 90 days of age

  • Serum Cytokine Levels

    Serum cytokine levels will be compared between infants who develop TR-NEC and matched controls who do not.

    Up to 90 days of age

Other Outcomes (3)

  • Image Analysis Algorithm

    Up to 90 days of age

  • Development of a Clustering Method for Identification of Anemia

    Up to 90 days of age

  • Image Analysis Algorithm

    Up to 90 days of age

Study Arms (4)

ELBW Infants with Prolonged Irradiation Storage Time

Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion had prolonged Irradiation Storage Time (IST) being tested with metabolomics profile.

Device: Near Infrared Spectroscopy

ELBW Infants without Irradiation Storage

Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion did not have Irradiation Storage being tested with metabolomics profile.

Device: Near Infrared Spectroscopy

ELBW Infants Reaching the NEC Window

Extremely low birth weight infants who reach 28 to 34 postmenstrual week age, which is the NEC window.

Other: Non-invasive Image-based Anemia Assessment

ELBW Infants

Extremely low birth weight infants having intestinal microbial profiles examined via stool collected from discarded diapers, and immune cell function and serum cytokine levels examined using residual blood.

Interventions

Near Infrared SpectroscopyDEVICE

INVOS 5100C Cerebral/Somatic Oximeter is an FDA-approved device used to measure renal and mesenteric tissue oxygenation, as defined by regional oxygenation saturation levels (rSO2). Two probe site monitoring will be used to evaluate differential tissue bed oxygenation. Adhesive sensor probes are applied to the periumbilical area for mesenteric monitoring and to the flank area for renal monitoring.

Also known as: NIRS
ELBW Infants with Prolonged Irradiation Storage TimeELBW Infants without Irradiation Storage
Non-invasive Image-based Anemia AssessmentOTHER

A trained research associate will take 2 images (one with the camera flash on and one with the camera flash off) of the patient's fingernail beds, toe nail beds, palm of the hand and sole of the foot. Images will be taken within 24 hours, preceding, or following, each complete blood count (CBC) collection on each consented patient. The anemia diagnosing algorithm will then be run on the images.

ELBW Infants Reaching the NEC Window

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Extremely low birth weight newborn infants born at Emory University Hospital Midtown, Grady Health System, and Northside Hospital Neonatology. Infants will be followed at Children's Healthcare of Atlanta.

You may qualify if:

  • Birth weight ≤1250 grams
  • Postnatal age within 7 days of birth

You may not qualify if:

  • Infant not expected to live beyond 7 days of life based on assessment of treating neonatologist
  • Severe congenital abnormality expected to affect life expectancy
  • RBC or platelet transfusion at an outside institution occurring prior to screening
  • Maternal refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Northside Hospital - Neonatology

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

  • Marin T, Patel RM, Roback JD, Stowell SR, Guo Y, Easley K, Warnock M, Skvarich J, Josephson CD. Does red blood cell irradiation and/or anemia trigger intestinal injury in premature infants with birth weight </= 1250 g? An observational birth cohort study. BMC Pediatr. 2018 Aug 11;18(1):270. doi: 10.1186/s12887-018-1241-5.

    PMID: 30098602DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual patient blood samples (obtained for routine clinical testing), urine, stool and breast milk will be collected, frozen and stored. If a baby develops a digestive tract complication, the stored specimens will be studied in the laboratory in an effort to identify markers of a healthy digestive tract versus illness. A sample of transfused RBCs will be obtained from the RBC unit at each RBC transfusion. If the baby develops a digestive tract complication the stored specimens will be studied in the laboratory to identify changes in the biochemical compounds of the transfused blood that may have taken place over time.

MeSH Terms

Conditions

AnemiaEnterocolitis, Necrotizing

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ravi Patel, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 18, 2016

Study Start

July 1, 2016

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)