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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03643458
Other study ID # SO-2014-NIRS
Secondary ID 122/2012/U/Oss
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date June 30, 2014

Study information

Verified date September 2018
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Premature neonates are among the most transfused population, but the risks and benefits of this procedure remain unclear. 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 common and feared gastrointestinal complications of prematurity. Several observational studies have tried to demonstrate this causal correlation, defining the so-called transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.

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. This evidence, which has been hypothesized to play a role on the risk of TANEC development, has significantly raised the attention over the feeding plans during and after RBC transfusion.

To date, splanchnic oxygenation response to feeds before and after transfusion has not been investigated, but could bring useful information to understand the splanchnic hemodynamic changes associated to RBC transfusion.

Therefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.

Enrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2) oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal sensors will be placed in the central region of the forehead and the below the umbilicus, respectively.

The study monitoring includes the following phases:

- Phase 1 (0-3 hours): pre-transfusion feed and related post-prandial period

- Phase 2 (4-9 hours): RBC transfusion (10 ml/kg),administered over 3 hours, following which feeds are hold for 3 hours.

- Phase 3 (10-12 hours): post-transfusion feed and related post-prandial period.

CrSO2 and SrSO2 patterns before and after transfusion and the related changes from baseline values will be analyzed. SCOR (CrSO2/SrSO2 ratio) patterns will be also calculated and analyzed. IBM SPSS Statistics (Statistical Package for the Social Sciences, SPSS Inc., IBM, Armonk, NY) will be used for statistical analysis. If any infant develops TANEC after transfusion, the related patterns will be evaluated and analyzed separately.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Italy Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital Bologna

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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

Outcome

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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