The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation

Study Overview
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Brief Summary
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This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.

Detailed Description
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Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard. Restricted Transfusion Guidelines will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion. Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion. Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion. Group 3: The same feeding volume will be continued without decreasing or stopping. Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline. The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.

Official Title
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The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Device: NIRS (near-infrared spectroscopy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prematurity (<32 completed weeks of gestation at birth) Need for PRBC transfusion Feeding at least 30ml/kg/day at the time of transfusion Exclusion Criteria: Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia. Infants receiving continuous feeds or less than 30ml/kg/day Major congenital or chromosomal abnormalities or infants unlikely to survive Intraventricular hemorrhage >Grade 3 Hemodynamically significant patent ductus arteriosus Infants requiring vasopressor support Skin disruption precluding application of sensors

Ages Eligible for Study
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Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1: no enteral feeding<br>intervention: NIRS (near-infrared spectroscopy) | Device: NIRS (near-infrared spectroscopy)<br>* mesenteric oxygenisation measurement<br>|
| Other: Group 2: Feeding is reduced by %50<br>intervention: NIRS (near-infrared spectroscopy) | Device: NIRS (near-infrared spectroscopy)<br>* mesenteric oxygenisation measurement<br>|
| Other: Group 3: Feeding will be continued<br>intervention: NIRS (near-infrared spectroscopy) | Device: NIRS (near-infrared spectroscopy)<br>* mesenteric oxygenisation measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion) | number of participants that has low mesenteric oxygenisation after transfusion | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding intolerance (number of participants that has feeding intolerance after transfusion) | number of participants that has feeding intolerance after transfusion | starting with transfusion until discharge, assessed up to 12 weeks | 
| NEC (number of participants that has occurred transfusion related NEC) | number of participants that has occurred transfusion related NEC | starting with transfusion until discharge, assessed up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing enterocolitis, Transfusion, Mesenteric Oxygenisation