Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
Condition: Blood Transfusion Complication; Necrotizing Enterocolitis; Enteral Feeding Intolerance; Preterm Infant
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Premature Birth; Transfusion Reaction
Study type: Observational

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.
    

Detailed 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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anemic preterm infants requiring red blood cell transfusion.
      
Keywords: NIRS; TANEC; splanchnic oxygenation; enteral feeding; preterm infants