Withholding Feeds During Red Blood Cell Transfusion and TRAGI

NCT02132819 | Unknown Phase 4

• 1 other identifier: Sahin1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

transfusion; feeding; TRAGI; NEC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• increase in the amounts of gastric residual aspirates

  Within 3 days after the transfusion

Other Outcomes (1)

• occult or obvious blood in stool

  within 1 day after transfusion

Study Arms (2)

Feeding During Transfusion

PLACEBO COMPARATOR

The feeding process will be continued during the transfusion

Other: feeding during transfusion

witholding feeds

ACTIVE COMPARATOR

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

Other: Withholding feeds

Interventions

Withholding feeds OTHER

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

witholding feeds

feeding during transfusion OTHER

The feeding process will be continued during the transfusion

Feeding During Transfusion

Eligibility Criteria

• Age: 7 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<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.

You may not qualify if:

• Babies with severe sepsis signs.
• Babies with severe hypoxia and asphyxia.
• Babies with congenital anomaly or complex cardiac anomaly.

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Suzan Sahin

Ankara, Altındag, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Suzan Sahin, MD

  Zekai Tahir Burak Women's Health Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzan Sahin, MD

CONTACT

suzan_balkan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Neonatology, Pediatrician

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: May 7, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

TU (1)