Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/9/2018 |
| Start Date: | September 2018 |
| End Date: | June 2020 |
| Contact: | Edmund LaGamma, MD |
| Email: | edmund_lagamma@nymc.edu |
| Phone: | 914-493-8558 |
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.
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.
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
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
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)
We found this trial at
4
sites
1001 E 5th St
Greenville, North Carolina 27858
Greenville, North Carolina 27858
(252) 328-6131
Phone: 252-744-1111
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Valhalla, New York 10595
Principal Investigator: Ed LaGamma, MD
Phone: 914-493-8558
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