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

April 22, 2019 updated by: Edmund LaGamma, New York Medical College

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
    • New York
      • Stony Brook, New York, United States, 11794
        • Suspended
        • Stony Brook Children's Hospital
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Maria Fareri Childrens Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ed LaGamma, MD
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Medical College

Collaborators

New York University
Stony Brook University
Baystate Medical Center
East Carolina University

Investigators

  • Principal Investigator: Edmund LaGamma, MD, New York Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2019

Primary Completion (Anticipated)

February 5, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDA IND 126254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of the primary manuscript.

IPD Sharing Time Frame

After publication of the primary manuscript

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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