Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO (iNO-TRAGI)
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|ClinicalTrials.gov Identifier: NCT02851472|
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Inhaled Nitric Oxide Drug: Placebo||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||subjects are randomize into either of two groups: intervention or placebo|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||iNO vs nitrogen will be administered from tanks labeled with a code number that is known by the manufacturer and a campus safety officer but masked to investigators and to bedside personnel.|
|Official Title:||Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGAN) Neonates Using iNO|
|Actual Study Start Date :||February 6, 2019|
|Estimated Primary Completion Date :||February 5, 2021|
|Estimated Study Completion Date :||June 30, 2021|
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 Name: 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
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 Name: Control
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851472
|Contact: Edmund LaGamma, MDfirstname.lastname@example.org|
|Contact: Gad Alpan, MDemail@example.com|
|United States, Massachusetts|
|Baystate Children's Hospital||Recruiting|
|Springfield, Massachusetts, United States, 01199|
|Contact: Rachana Singh, MD 413-794-2207 firstname.lastname@example.org|
|United States, New York|
|Stony Brook Children's Hospital||Suspended|
|Stony Brook, New York, United States, 11794|
|Maria Fareri Childrens Hospital||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Ed LaGamma, MD 914-493-8558 email@example.com|
|Contact: Gad Alpan, MD 914 493 8558 firstname.lastname@example.org|
|Principal Investigator: Ed LaGamma, MD|
|United States, North Carolina|
|East Carolina University||Recruiting|
|Greenville, North Carolina, United States, 27834|
|Contact: Uduak Akpan, MD 252-744-1111 email@example.com|
|Principal Investigator:||Edmund LaGamma, MD||New York Medical College|