Withholding Feeds During Red Blood Cell Transfusion and TRAGI (Tx-TRAGI)

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 4

Conditions: Feeding During Transfusion; Necrotising Enterocolitis; Transfusion; Transfusion Related Acute Gut Injury

Treatments: Other: Withholding feeds; Other: feeding during transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02132819

Sahin1

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 7 days to 3 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Feeding During Transfusion

Placebo Comparator group

Description:

The feeding process will be continued during the transfusion

Treatment:

Other: feeding during transfusion

witholding feeds

Active Comparator group

Description:

At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

Treatment:

Other: Withholding feeds