Necrotizing Enterocolitis Clinical Trial
— NIRS_RBCOfficial title:
Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor
for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal
complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood
flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic
oxygenation after RBC transfusion; a possible role for these findings in increasing the risk
for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and
after transfusion.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2014 |
Est. primary completion date | June 30, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Months |
Eligibility |
Inclusion Criteria: - gestational age <32 weeks or birth weight <1500 g - need for red blood cell transfusion according to national guidelines Exclusion Criteria: - hemodynamic instability - Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion |
Country | Name | City | State |
---|---|---|---|
Italy | Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Bailey SM, Hendricks-Muñoz KD, Mally PV. Variability in splanchnic tissue oxygenation during preterm red blood cell transfusion given for symptomatic anaemia may reveal a potential mechanism of transfusion-related acute gut injury. Blood Transfus. 2015 Jul;13(3):429-34. doi: 10.2450/2015.0212-14. Epub 2015 Jan 30. — View Citation
Banerjee J, Leung TS, Aladangady N. Blood transfusion in preterm infants improves intestinal tissue oxygenation without alteration in blood flow. Vox Sang. 2016 Nov;111(4):399-408. doi: 10.1111/vox.12436. Epub 2016 Aug 10. — View Citation
Banerjee J, Leung TS, Aladangady N. Effect of blood transfusion on intestinal blood flow and oxygenation in extremely preterm infants during first week of life. Transfusion. 2016 Apr;56(4):808-15. doi: 10.1111/trf.13434. Epub 2015 Dec 8. — View Citation
Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19. — View Citation
Marin T, Josephson CD, Kosmetatos N, Higgins M, Moore JE. Feeding preterm infants during red blood cell transfusion is associated with a decline in postprandial mesenteric oxygenation. J Pediatr. 2014 Sep;165(3):464-71.e1. doi: 10.1016/j.jpeds.2014.05.009. Epub 2014 Jun 16. — View Citation
Marin T, Moore J, Kosmetatos N, Roback JD, Weiss P, Higgins M, McCauley L, Strickland OL, Josephson CD. Red blood cell transfusion-related necrotizing enterocolitis in very-low-birthweight infants: a near-infrared spectroscopy investigation. Transfusion. 2013 Nov;53(11):2650-8. doi: 10.1111/trf.12158. Epub 2013 Mar 11. — View Citation
White L, Said M, Rais-Bahrami K. Monitoring mesenteric tissue oxygenation with near-infrared spectroscopy during packed red blood cell transfusion in preterm infants. J Neonatal Perinatal Med. 2015;8(2):157-63. doi: 10.3233/NPM-15814090. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-transfusion splanchnic oxygenation pattern | Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value | Enteral feed before red blood cell transfusion administration (3 hours) | |
Primary | Post-transfusion splanchnic oxygenation pattern | Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value | Enteral feed after red blood cell transfusion administration (3 hours) | |
Secondary | Incidence of gut complications | Occurrence of necrotizing enterocolitis or feeding intolerance in infants undergone red blood cell transfusion | 48 hours after transfusion |
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