- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083638
The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants
September 6, 2019 updated by: Senem Alkan Özdemir, Dr. Behcet Uz Children's Hospital
Investigation of the Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants: a Randomized Controlled Clinical Trial
In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Senem A Özdemir, MD
- Phone Number: 05327614670
- Email: drsenemalkan@yahoo.com
Study Contact Backup
- Name: Şebnem A Çalkavur, MD
- Phone Number: 05327614670
- Email: sebnemcalkavur@yahoo.com
Study Locations
-
-
Izmir
-
İzmirli, Izmir, Turkey, 35210
- Recruiting
- Behcet Uz Children's Hospital
-
Contact:
- Senem A Özdemir, MD
- Phone Number: 5327614670
- Email: drsenemalkan@yahoo.com
-
Contact:
- Senem Alkan Ozdemir, MD
- Phone Number: 05327614670
- Email: drsenemalkan@yahoo.com
-
Sub-Investigator:
- Rüya Çolak, MD
-
-
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
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Preterm infants
Description
Inclusion Criteria:
- <32 gestational week and/or <1500 g birth weight
Exclusion Criteria:
- Major congenital anomalies, hemodynamic instability
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Control group
|
Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx
|
Group 2
Feeding will not stop during the transfusion
|
Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
necrotizing enterocolitis
Time Frame: 0-48 hours after tx
|
0-48 hours after tx
|
|
Mortality
Time Frame: 0-24 hour after tx
|
If all babies die after tx study will be finished
|
0-24 hour after tx
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Rüya Çolak, MD, Behcet Uz Children's 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 (Anticipated)
January 1, 2020
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 6, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/279
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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