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RBC Irradiation, Anemia and Gut Injury (RBC-mNIRS)

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: NCT02741648
Recruitment Status : Unknown
Verified April 2021 by Cassandra D Josephson, Emory University.
Recruitment status was:  Recruiting
First Posted : April 18, 2016
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Cassandra D Josephson, Emory University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Anemia Necrotizing Enterocolitis Device: Near Infrared Spectroscopy

Detailed Description:

Anemia and digestive tract complications are common problems in Extremely Low Birth Weight infants. Anemia is a condition in which the body does not have enough red blood cells (RBC). RBCs are important because they contain hemoglobin, the substance that carries oxygen throughout the body. Transfusions of RBCs in these infants is frequently required to correct the anemia. Oxygen levels in the digestive tract will be measured before, during and after each blood transfusion using a tissue oxygen monitor called Near Infrared Spectroscopy (NIRS). By using this technology, better understanding can be obtained of intestinal blood flow patterns.

In addition, ELBW infants are more likely to have immature digestive systems and are at risk for digestive tract problems such as necrotizing enterocolitis (NEC). NEC is a disease characterized by infection and decreased blood flow to the intestines. NEC is a major cause of devastating illness and death in this vulnerable preterm population. Leftover blood samples, urine, stool, and breast milk samples will be collected, frozen, and stored. In the event a baby develops a digestive tract complication they will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness.

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 1250 Grams
Study Start Date : July 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.
Other Name: NIRS
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
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.
Other Name: NIRS
ELBW Infants with NEC
Extremely Low Birth Weight Infants with Necrotizing Enterocolitis (NEC defined as "Bell's Stage II or greater) and receiving Red Blood Cell (RBC) Transfusions being tested with Near Infrared Spectroscopy.
 Device: Near Infrared Spectroscopy
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.
Other Name: NIRS
ELBW Infants without NEC
Extremely Low Birth Weight Infants without Necrotizing Enterocolitis being tested with Near Infrared Spectroscopy.
 Device: Near Infrared Spectroscopy
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.
Other Name: NIRS


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Mesenteric Tissue Oxygenation [ Time Frame: 60 Minutes prior to transfusion to 48 hours after transfusion ]
    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.

  2. Changes in Mesenteric Tissue Oxygenation [ Time Frame: Week 30 to Week 34 Post Menstrual Age ]
    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).


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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT02741648


Contacts
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Contact: Cassandra Josephson, MD 404-785-4553 cjoseph@emory.edu
Contact: Hailly Butler, RN 404 712-8895 hailly.butler@emory.edu

Locations
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United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Cassandra Josephson, MD    404-785-4553    cjoseph@emory.edu   
Contact: Hailly Butler, RN    404 712-8895    hailly.butler@emory.edu   
Principal Investigator: Cassandra Josephson, MD         
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Cassandra Josephson, MD    404-785-4553    cjoseph@emory.edu   
Contact: Hailly Butler, RN    404 712-8895    hailly.butler@emory.edu   
Principal Investigator: Cassandra Josephson, MD         
Northside Hospital - Neonatology Recruiting
Atlanta, Georgia, United States, 30342
Contact: Michael Hinkes, MD    404-785-4553    Mike_Hinkes@pediatrix.com   
Contact: Katrina Grier       khgrier@gmail.com   
Sub-Investigator: Michael Hinkes, MD         
Sponsors and Collaborators
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Cassandra Josephson, MD Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cassandra D Josephson, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02741648    
Other Study ID Numbers: IRB00083691
2P01HL086773 ( U.S. NIH Grant/Contract )
1R01HL138714 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Cassandra D Josephson, Emory University:
Red Blood Cell Transfusion
Digestive tract problems
Extremely Low Birth Weight
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Anemia
Hematologic Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases