Withholding Feeds During Red Blood Cell Transfusion and TRAGI

Study Overview
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Brief Summary
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Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.

Official Title
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The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants

Conditions
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Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis

Intervention / Treatment
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* Other: Withholding feeds
* Other: feeding during transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <32 weeks of gestational age or <1500 gr, >7 days old premature babies. Babies which are fed enterally well at the time of tha planning of transfusion. Exclusion Criteria: Babies with severe sepsis signs. Babies with severe hypoxia and asphyxia. Babies with congenital anomaly or complex cardiac anomaly.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 3 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Feeding During Transfusion<br>The feeding process will be continued during the transfusion | Other: feeding during transfusion<br>* The feeding process will be continued during the transfusion<br>|
| Active Comparator: witholding feeds<br>At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded | Other: Withholding feeds<br>* At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in the abdominal circumference | Bell's stage 1/Suspected disease: Mild systemic disease (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs Bell's stage 2/Definite disease: Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) Bell's stage 3/Advanced disease: Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiologic signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulation) | within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in the amounts of gastric residual aspirates |  | Within 3 days after the transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion, feeding, TRAGI, NEC