Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO
NCT ID: NCT02851472
Last Updated: 2019-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2019-02-06
2021-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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.
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
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Weeks
ALL
No
Sponsors
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Stony Brook University
OTHER
Baystate Medical Center
OTHER
East Carolina University
OTHER
New York University
OTHER
New York Medical College
OTHER
Responsible Party
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Edmund LaGamma
Chief of Neonatology
Principal Investigators
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Edmund LaGamma, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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Baystate Children's Hospital
Springfield, Massachusetts, United States
Stony Brook Children's Hospital
Stony Brook, New York, United States
Maria Fareri Childrens Hospital
Valhalla, New York, United States
East Carolina University
Greenville, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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La Gamma EF, Blau J. Transfusion-related acute gut injury: feeding, flora, flow, and barrier defense. Semin Perinatol. 2012 Aug;36(4):294-305. doi: 10.1053/j.semperi.2012.04.011.
Mintzer JP, Parvez B, Chelala M, Alpan G, LaGamma EF. Monitoring regional tissue oxygen extraction in neonates <1250 g helps identify transfusion thresholds independent of hematocrit. J Neonatal Perinatal Med. 2014 Jan 1;7(2):89-100. doi: 10.3233/NPM-1477213.
Mintzer JP, Parvez B, La Gamma EF. Regional Tissue Oxygen Extraction and Severity of Anemia in Very Low Birth Weight Neonates: A Pilot NIRS Analysis. Am J Perinatol. 2018 Dec;35(14):1411-1418. doi: 10.1055/s-0038-1660458. Epub 2018 Jun 15.
Mintzer JP, Parvez B, Alpan G, LaGamma EF. Effects of sodium bicarbonate correction of metabolic acidosis on regional tissue oxygenation in very low birth weight neonates. J Perinatol. 2015 Aug;35(8):601-6. doi: 10.1038/jp.2015.37. Epub 2015 Apr 30.
Mintzer JP, Parvez B, La Gamma EF. Umbilical Arterial Blood Sampling Alters Cerebral Tissue Oxygenation in Very Low Birth Weight Neonates. J Pediatr. 2015 Nov;167(5):1013-7. doi: 10.1016/j.jpeds.2015.08.016. Epub 2015 Sep 1.
LaGamma, EF, Feldman, A, Mintzer, J, Lakshminrusimha, S, Alpan, G. Red Blood Cell Storage in Transfusion-Related Acute Gut Injury. NeoReviews 16 (7): e420-e430, 2015
Other Identifiers
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FDA IND 126254
Identifier Type: -
Identifier Source: org_study_id
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