- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132819
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Suzan Sahin, MD
- Email: suzan_balkan@yahoo.com
Study Locations
-
-
Altındag
-
Ankara, Altındag, Turkey, 06230
- Recruiting
- Suzan Sahin
-
Contact:
- Suzan Sahin, MD
- Email: suzan_balkan@yahoo.com
-
Principal Investigator:
- Ugur Dilmen, Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Investigators
- Principal Investigator: Suzan Sahin, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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