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AnemiaPhase 1/2iNO-TRAGINCT02851472

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

A Phase 1/2 study testing Inhaled Nitric Oxide in people with Anemia, run by New York Medical College at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 weeks and older
Conditions the study is for
Anemia
What is being tested?
Inhaled Nitric Oxide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
4 sitesUnited States
Study dates
6 Feb 2019to 30 Jun 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

4 sites in 1 country.

Edmund LaGamma, MD contact

914-493-8558

edmund_lagamma@nymc.edu

Gad Alpan, MD contact

914-493-8558

gad_alpan@nymc.edu

United States4 sites, 3 recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Uduak Akpan, MD, 252-744-1111, akpanu@ecu.edu

    Recruiting

  • Baystate Children's Hospital

    Springfield, Massachusetts, 01199

    Rachana Singh, MD, 413-794-2207, rachana.singhmd@baystatehealth.org

    Recruiting

  • Stony Brook Children's Hospital

    Stony Brook, New York, 11794

    Suspended

  • Maria Fareri Childrens Hospital

    Valhalla, New York, 10595

    Ed LaGamma, MD, 914-493-8558, edmund_lagamma@nymc.edu

    Gad Alpan, MD, 914 493 8558, gad_alpan@nymc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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

Conditions
Anemia
Being tested
Inhaled Nitric Oxide, Placebo
Keywords
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)
Medical subject headings
Anemia, Premature Birth, Enterocolitis, Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled Nitric OxideDrug

    Also called iNO

    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.

  • PlaceboDrug

    Also called Control

    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.

Study groups in NCT02851472
Study groupRoleWhat they receive
Inhaled Nitric OxideExperimentaliNO 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
Receives: Drug: Inhaled Nitric Oxide
PlaceboActive comparatorPlacebo 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo

    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.

    Measured: 19 hours

Secondary outcomes (1)

  1. Lower fractional tissue oxygen extraction (FTOE) in iNO treated neonates after PRBC transfusion vs Placebo

    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.

    Measured: 19 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study start6 Feb 2019
  3. Primary completion5 Feb 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
subjects are randomize into either of two groups: intervention or placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851472
Sponsor's protocol ID
FDA IND 126254
Acronym
iNO-TRAGI
Status last verified
Apr 2019
First submitted
20 Jul 2016
Last updated
24 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After publication of the primary manuscript.

Publications

  • 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.

    PubMed 22818551

  • 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.

    PubMed 25104129

  • 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.

    PubMed 29906796

  • 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.

    PubMed 25927273

  • 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.

    PubMed 26340878

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Inhaled Nitric Oxide in people with Anemia, run by New York Medical College at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Edmund LaGamma, MD (914-493-8558, edmund_lagamma@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo (time frame: 19 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02851472, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.

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