The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation

April 8, 2016 updated by: Marmara University
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard.

"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.

Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.

Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.

Group 3: The same feeding volume will be continued without decreasing or stopping.

Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline.

The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Marmara University School of Medicine
        • Contact:

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 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prematurity (<32 completed weeks of gestation at birth)
  • Need for PRBC transfusion
  • Feeding at least 30ml/kg/day at the time of transfusion

Exclusion Criteria:

  • Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
  • Infants receiving continuous feeds or less than 30ml/kg/day
  • Major congenital or chromosomal abnormalities or infants unlikely to survive
  • Intraventricular hemorrhage >Grade 3
  • Hemodynamically significant patent ductus arteriosus
  • Infants requiring vasopressor support
  • Skin disruption precluding application of sensors

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1: no enteral feeding
intervention: NIRS (near-infrared spectroscopy)
Device: NIRS (near-infrared spectroscopy)
mesenteric oxygenisation measurement
Other: Group 2: Feeding is reduced by %50
intervention: NIRS (near-infrared spectroscopy)
Device: NIRS (near-infrared spectroscopy)
mesenteric oxygenisation measurement
Other: Group 3: Feeding will be continued
intervention: NIRS (near-infrared spectroscopy)
Device: NIRS (near-infrared spectroscopy)
mesenteric oxygenisation measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
Time Frame: 48 hours
number of participants that has low mesenteric oxygenisation after transfusion
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding intolerance (number of participants that has feeding intolerance after transfusion)
Time Frame: starting with transfusion until discharge, assessed up to 12 weeks
number of participants that has feeding intolerance after transfusion
starting with transfusion until discharge, assessed up to 12 weeks
NEC (number of participants that has occurred transfusion related NEC)
Time Frame: starting with transfusion until discharge, assessed up to 12 weeks
number of participants that has occurred transfusion related NEC
starting with transfusion until discharge, assessed up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Hülya Selva Bilgen, MD, professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-01022016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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