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 Locations

  • Turkey
    • Izmir
      • İzmirli, Izmir, Turkey, 35210
        • Recruiting
        • Behcet Uz Children's Hospital
        • Contact:
        • Contact:
        • 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
Diagnostic test: IFAB
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
Diagnostic test: IFAB
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.

Sponsor

Dr. Behcet Uz Children's Hospital

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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