NCT02132819

Withholding Feeds During Red Blood Cell Transfusion and TRAGI

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 7 Days – 3 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Transfusion
• Feeding During Transfusion
• Transfusion Related Acute Gut Injury
• Necrotising Enterocolitis

Interventions

Type	Name	Description
OTHER	Withholding feeds	At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
OTHER	feeding during transfusion	The feeding process will be continued during the transfusion

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2014-05-07
• Last updated: 2014-05-07

Locations

1 site across 1 country: Turkey (Türkiye)