Recruiting
Phase 1
Phase 2

iNO

Sponsor:

New York Medical College

Code:

NCT02851472

Conditions

Anemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Inhaled Nitric Oxide

Placebo

Study Details

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.

Conditions

Anemia

Study ID

NCT02851472

Start date

Feb 6, 2019

Status verified date

Apr, 2019

Completion date

Jun 30, 2021

Anticipated

Primary completion date

Feb 5, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

Primary outcome measure

  • Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo [ Time Frame: 19 hours ]

Central Contacts and Locations

Central contacts

Edmund LaGamma, MD

914-493-8558edmund_lagamma@nymc.edu

Gad Alpan, MD

914-493-8558gad_alpan@nymc.edu

Locations

Baystate Children's Hospital

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Rachana Singh, MD

413-794-2207rachana.singhmd@baystatehealth.org

Maria Fareri Childrens Hospital

Recruiting

Valhalla, New York, United States, 10595

Contacts

Ed LaGamma, MD

914-493-8558edmund_lagamma@nymc.edu

Gad Alpan, MD

914 493 8558gad_alpan@nymc.edu

Principal Investigator:

Ed LaGamma, MD

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Uduak Akpan, MD

252-744-1111akpanu@ecu.edu

More Information

Sponsor

New York Medical College

Last update posted

Apr 24, 2019

Last verified

Apr, 2019

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Medical College on 2019-04-24.