Withholding Feeds During Red Blood Cell Transfusion and TRAGI

Phase 4

• Conditions: Transfusion; Feeding During Transfusion; Transfusion Related Acute Gut Injury; Necrotising Enterocolitis
• Interventions: Other: feeding during transfusion; Other: Withholding feeds

• Registration Number: NCT02132819
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-17
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07
• Primary Completion: 2015-01
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feeding During Transfusion	feeding during transfusion	The feeding process will be continued during the transfusion
witholding feeds	Withholding feeds	At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

Primary Outcome Measures

Name	Time	Method
increase in the abdominal circumference	within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks	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)

Secondary Outcome Measures

Name	Time	Method
increase in the amounts of gastric residual aspirates	Within 3 days after the transfusion

Trial Locations

Locations (1)

Suzan Sahin; 🇹🇷 Ankara, Altındag, Turkey