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

May 5, 2014 updated by: Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altındag
      • Ankara, Altındag, Turkey, 06230
        • Recruiting
        • Suzan Sahin
        • Contact:
        • Principal Investigator:
          • Ugur Dilmen, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Feeding During Transfusion
The feeding process will be continued during the transfusion
Other: feeding during transfusion
The feeding process will be continued during the transfusion
Active Comparator: witholding feeds
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
Other: Withholding feeds
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
increase in the amounts of gastric residual aspirates
Time Frame: Within 3 days after the transfusion
Within 3 days after the transfusion

Other Outcome Measures

Outcome Measure
Time Frame
occult or obvious blood in stool
Time Frame: within 1 day after transfusion
within 1 day after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Principal Investigator: Suzan Sahin, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sahin1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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