NCT02132819|UnknownPhase 4
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Tx-TRAGI
The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
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Tx-TRAGI
The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
Sponsor study identifier
interventional
150
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 17, 2014
Actual (reported)May 7, 2014
Actual (reported)January 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
increase in the amounts of gastric residual aspirates
Within 3 days after the transfusion
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
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
The feeding process will be continued during the transfusion
Suzan Sahin
Ankara, Altındag, 06230, Turkey (Türkiye)
Suzan Sahin, MD
Zekai Tahir Burak Women's Health Research and Education Hospital
First Submitted
April 17, 2014
First Posted
May 7, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications
occult or obvious blood in stool
within 1 day after transfusion
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 7, 2014
Record last verified: 2014-05
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