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

Primary Purpose

Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Withholding feeds
feeding during transfusion
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transfusion focused on measuring transfusion, feeding, TRAGI, NEC

Eligibility Criteria

7 Days - 3 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Suzan SahinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Feeding During Transfusion

witholding feeds

Arm Description

The feeding process will be continued during the transfusion

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

increase in the amounts of gastric residual aspirates

Full Information

First Posted
April 17, 2014
Last Updated
May 5, 2014
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02132819
Brief Title
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Acronym
Tx-TRAGI
Official Title
The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
Keywords
transfusion, feeding, TRAGI, NEC

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feeding During Transfusion
Arm Type
Placebo Comparator
Arm Description
The feeding process will be continued during the transfusion
Arm Title
witholding feeds
Arm Type
Active Comparator
Arm Description
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
Intervention Type
Other
Intervention Name(s)
Withholding feeds
Intervention Description
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
Intervention Type
Other
Intervention Name(s)
feeding during transfusion
Intervention Description
The feeding process will be continued during the transfusion
Primary Outcome Measure Information:
Title
increase in the abdominal circumference
Description
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)
Time Frame
within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary Outcome Measure Information:
Title
increase in the amounts of gastric residual aspirates
Time Frame
Within 3 days after the transfusion
Other Pre-specified Outcome Measures:
Title
occult or obvious blood in stool
Time Frame
within 1 day after transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan Sahin, MD
Email
suzan_balkan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Sahin, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzan Sahin
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzan Sahin, MD
Email
suzan_balkan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ugur Dilmen, Prof

12. IPD Sharing Statement

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Withholding Feeds During Red Blood Cell Transfusion and TRAGI

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