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

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ClinicalTrials.gov Identifier: NCT02741648
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Cassandra D Josephson, Emory University

Tracking Information
First Submitted Date April 13, 2016
First Posted Date April 18, 2016
Last Update Posted Date August 14, 2019
Study Start Date July 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2016)
  • 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.
  • 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).
Original Primary Outcome Measures
 (submitted: April 15, 2016)
  • Changes in Renal 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 flank area for renal monitoring.
  • 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.
  • Changes in Renal 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 flank area for renal 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).
  • 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).
Change History Complete list of historical versions of study NCT02741648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RBC Irradiation, Anemia and Gut Injury
Official Title Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants 1250 Grams
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

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.

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.
Condition
  • Anemia
  • Necrotizing Enterocolitis
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Near Infrared Spectroscopy
  • 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.
    Intervention: Device: Near Infrared Spectroscopy
  • ELBW Infants without NEC
    Extremely Low Birth Weight Infants without Necrotizing Enterocolitis being tested with Near Infrared Spectroscopy.
    Intervention: Device: Near Infrared Spectroscopy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 21, 2016)
220
Original Estimated Enrollment
 (submitted: April 15, 2016)
384
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Days   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Cassandra Josephson, MD 404-785-4553 cjoseph@emory.edu
Contact: Hailly Butler, RN 404 712-8895 hailly.butler@emory.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02741648
Other Study ID Numbers IRB00083691
2P01HL086773 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Cassandra D Josephson, Emory University
Study Sponsor Emory University
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Cassandra Josephson, MD Emory University
PRS Account Emory University
Verification Date August 2019