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Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO (iNO-TRAGI)

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ClinicalTrials.gov Identifier: NCT02851472
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Stony Brook University
Baystate Medical Center
East Carolina University
New York University
Information provided by (Responsible Party):
Edmund LaGamma, New York Medical College

Brief Summary:
The investigators seek to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a packed red blood cell transfusion (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled nitric oxide vs. placebo at these body sites to determine whether iNO will alter the fractional tissue oxygen extraction. Treatment and control groups will be compared to each other at equivalent epochs as will individual patients before, during and after the PRBC transfusion.

Condition or disease Intervention/treatment Phase
Anemia Drug: Inhaled Nitric Oxide Drug: Placebo Phase 1 Phase 2

Detailed Description:

Selection criteria: 1) Neonates 24 0/7 to 27 6/7 weeks gestational age (GA) 2) More than 2 weeks postnatal age. 3) Anemia with Hct less than 28 % 4) >50 % total daily fluids is enteral 5) History of at least 1 prior PRBC transfusion ELGANs admitted to the neonatal intensive care unit (NICU) will be screened for the study. If patients meet the selection criteria, parents will be approached to obtain informed consent. Then the patient will be randomized to either iNO or placebo group before treatment. The treating physician will make the decision regarding timing of the PRBC transfusion to treat anemia for the subject.

During the period of observation, near infrared spectroscopy (NIRS) monitoring will be performed on all enrolled subjects during which a non-invasive probe will be attached to the skin at 3 sites simultaneously- on abdomen below umbilicus, flank/back, and forehead for calculation of fractional tissue oxygen extraction ( FTOE) in conjunction with concurrent pulse oximetry recordings.

Conventional vital signs, blood gas, lactate, haptoglobin and cytokines will be measured before and after the PRBC transfusion

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects are randomize into either of two groups: intervention or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: iNO vs nitrogen will be administered from tanks labeled with a code number that is known by the manufacturer and a campus safety officer but masked to investigators and to bedside personnel.
Primary Purpose: Treatment
Official Title: Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGAN) Neonates Using iNO
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : February 5, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhaled Nitric Oxide
iNO will be given at 20 ppm, continuous, via inhalation before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
Drug: Inhaled Nitric Oxide
Nitric oxide gas will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems adapted specifically for this study.
Other Name: iNO

Active Comparator: Placebo
Placebo gas (nitrogen) will be given continuous, via inhalation at the same ppm, before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
Drug: Placebo
Placebo gas (nitrogen) will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems specifically adapted for this study.
Other Name: Control




Primary Outcome Measures :
  1. Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo [ Time Frame: 19 hours ]
    The investigators hypothesize that NIRS signal will be significantly higher in the iNO treated group during the 2nd hour after transfusion is concluded vs Placebo. NIRS will be measured continuously and averaged every 5 minutes to create a single hourly point for each subject before and after the transfusion for statistical analysis.


Secondary Outcome Measures :
  1. Lower fractional tissue oxygen extraction (FTOE) in iNO treated neonates after PRBC transfusion vs Placebo [ Time Frame: 19 hours ]
    FTOE will be calculated from the 5 minute epochs of the recorded pulse oximeter and NIRS devices. The investigators hypothesize that FTOE will be significantly lower (i.e. improved) in the iNO treated group during the 2nd hour after transfusion is concluded vs Placebo. One entire hour before and another after the transfusion will be combined for each patient for statistical analysis.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates 24 0/7 to 27 6/7 weeks gestational age
  • More than 2 weeks postnatal age.
  • Anemia with hematocrit (Hct) less than 28 %
  • More than 50 % total daily fluids is enteral
  • History of at least 1 prior PRBC transfusion (preferably same donor)

Exclusion Criteria:

  • Prior history of necrotizing enterocolitis (NEC) to avoid a confounder
  • Clinically significant patent ductus arteriosus (PDA) requiring treatment (Rx) within 24h
  • Hypotensive for age or active bleeding
  • < 50% of total fluids are enteral (breast milk or formula)
  • Major congenital or surgical malformations
  • Known chromosomal anomalies detected by antepartum testing or direct physical examination with subsequent postnatal laboratory confirmation
  • Absence of parental or treating physician consent
  • A concurrent randomized clinical trial (RCT) with another randomized drug
  • Death expected < 48h
  • Another major concern by the treating physician that either mandates or prohibits study treatment such as known adverse reaction to prior transfusion (Tx)

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): NCT02851472


Contacts
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Contact: Edmund LaGamma, MD 914-493-8558 edmund_lagamma@nymc.edu
Contact: Gad Alpan, MD 914-493-8558 gad_alpan@nymc.edu

Locations
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United States, Massachusetts
Baystate Children's Hospital Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Rachana Singh, MD    413-794-2207    rachana.singhmd@baystatehealth.org   
United States, New York
Stony Brook Children's Hospital Suspended
Stony Brook, New York, United States, 11794
Maria Fareri Childrens Hospital Recruiting
Valhalla, New York, United States, 10595
Contact: Ed LaGamma, MD    914-493-8558    edmund_lagamma@nymc.edu   
Contact: Gad Alpan, MD    914 493 8558    gad_alpan@nymc.edu   
Principal Investigator: Ed LaGamma, MD         
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Uduak Akpan, MD    252-744-1111    akpanu@ecu.edu   
Sponsors and Collaborators
New York Medical College
Stony Brook University
Baystate Medical Center
East Carolina University
New York University
Investigators
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Principal Investigator: Edmund LaGamma, MD New York Medical College
Publications of Results:
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Responsible Party: Edmund LaGamma, Chief of Neonatology, New York Medical College
ClinicalTrials.gov Identifier: NCT02851472    
Other Study ID Numbers: FDA IND 126254
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of the primary manuscript.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After publication of the primary manuscript
Access Criteria: Data available if there is a well thought-out plan from a credible investigator who is exeprineced in neonatology, transfusion medicine or control of the microcirculation via nitric oxide.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edmund LaGamma, New York Medical College:
TRAGI (transfusion related acute gut injury)
inhaled nitric oxide (iNO)
prematurity
PRBC transfusion
NEC (necrotizing enterocolitis)
NIRS (near infrared spectroscopy)
ELGAN (extremely low gestational age neonate)
Additional relevant MeSH terms:
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Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents