Withholding Feeds During Red Blood Cell Transfusion and TRAGI

Transfusion Clinical Trial

— Tx-TRAGI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02132819
• Other study ID #: Sahin1
• Status: Recruiting
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: May 5, 2014
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Suzan Sahin, MD
• Email: suzan_balkan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Withholding feeds
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
• feeding during transfusion
The feeding process will be continued during the transfusion

Locations

Country	Name	City	State
Turkey	Suzan Sahin	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	occult or obvious blood in stool		within 1 day after transfusion	Yes
Primary	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	Yes
Secondary	increase in the amounts of gastric residual aspirates		Within 3 days after the transfusion	Yes