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

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ClinicalTrials.gov Identifier: NCT02132819
Recruitment Status : Unknown
Verified May 2014 by Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Suzan Sahin, 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.

Condition or disease Intervention/treatment Phase
Transfusion Feeding During Transfusion Transfusion Related Acute Gut Injury Necrotising Enterocolitis Other: Withholding feeds Other: feeding during transfusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
Study Start Date : February 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. increase in the amounts of gastric residual aspirates [ Time Frame: Within 3 days after the transfusion ]

Other Outcome Measures:
  1. occult or obvious blood in stool [ Time Frame: within 1 day after transfusion ]


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132819


Contacts
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Contact: Suzan Sahin, MD suzan_balkan@yahoo.com

Locations
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Turkey
Suzan Sahin Recruiting
Ankara, Altındag, Turkey, 06230
Contact: Suzan Sahin, MD       suzan_balkan@yahoo.com   
Principal Investigator: Ugur Dilmen, Prof         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Principal Investigator: Suzan Sahin, MD Zekai Tahir Burak Women's Health Research and Education Hospital

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Responsible Party: Suzan Sahin, Fellow in Neonatology, Pediatrician, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02132819     History of Changes
Other Study ID Numbers: Sahin1
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital:
transfusion
feeding
TRAGI
NEC

Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases