Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants (TANEC)

October 7, 2024 updated by: Hakan Ongun, Akdeniz University

Impact of Enteral Feeding on Cerebral and Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants: a Prospective Randomized Controlled Study

This clinical trial aims to learn if enteral feeding influences cerebral and splanchnic oxygenation during red blood cell infusion in very low birth-weight preterm infants. It will also learn about how continuing or withholding enteral feeding during blood transfusion might trigger transfusion-related necrotizing enterocolitis. The main questions, it aims to answer are:

  • Does continuing or withholding enteral feeding have any impact on splanchnic and cerebral oxygenation in very-low-birth-weight preterm infants?
  • Does continuing enteral feeding result in feeding intolerance during red blood cell infusion or transfusion-related necrotizing enterocolitis (TANEC) in very-low-birth-weight preterm infants? Researchers will compare regional cerebral and splanchnic oxygenation obtained by Near Infra-Red Spectroscopy (NIRS) monitoring while receiving red blood cell transfusion.

Participants will:

  • Continue or withhold enteral feeding during red blood cell infusion, and all participants will be under NIRS monitoring for the following 48 hours after the blood transfusion.
  • Be monitored for any signs and symptoms of new-onset feeding intolerance and/or necrotizing enterocolitis for 48 hours following the blood transfusion

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Continuing enteral feeding during red blood cell transfusion can have a negative impact on cerebral and splanchnic oxygenation and trigger transfusion-related necrotizing enterocolitis (TANEC) in very low birth-weight infants of gestational age less than 32 weeks and/or birthweight less than 1500 grams. However, the issue of continuing or withholding enteral feeding to prevent TANEC in these neonates is a matter of debate. Enteral feeding is often withheld during blood transfusion to prevent TANEC.

This study was carried out to investigate the effect of enteral feeding during red blood cell infusion on cerebral and splanchnic oxygenation in low-birth-weight preterm infants. Secondary hypothesis was to observe (if any) the signs and symptoms of a new-onset feeding intolerance and/or necrotizing enterocolitis for 48 hours following the blood transfusion.

Enteral feeding will continue or be withhold in very low birthweight neonates during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation were measured using near-infrared spectroscopy (NIRS) for 48 hours.

Study Type

Interventional

Enrollment (Actual)

45

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 Locations

  • Turkey
    • Konyaalti
      • Antalya, Konyaalti, Turkey, 07000
        • Akdeniz University Faculty of Medicine

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. infants with gestational age ≤32 weeks and/or birthweight ≤1500 gr,
  2. survival at least the first week of life
  3. being able to tolerate a minimum total daily feeding volume of 100 mL/kg/day,
  4. hemodynamically stable infant (no need of inotropic support)
  5. receiving packed red blood cell transfusion for the treatment of anemia of prematurity

Exclusion criteria:

  1. feeding intolerance
  2. newly or previously diagnosed stage II and greater necrotizing enterocolitis
  3. spontaneous intestinal perforation
  4. suspected / proven sepsis in the previous 72 hours
  5. neonates in need of high-frequency oscillated ventilation support,
  6. previous PRBC transfusions due to iatrogenic anemia, hemolysis and/or intraventricular hemorrhage to avoid sensitization by blood products,
  7. hemodynamically significant patent ductus arteriosus
  8. history of abdominal surgery,
  9. complex congenital anomalies involving gastrointestinal tract and cardiovascular system,
  10. missing data,
  11. parental reluctance to consent.

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
Active Comparator: Feeding continued arm
Enteral feeding will continue during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation will be measured using near-infrared spectroscopy (NIRS) for 48 hours. Cerebral and splanchnic oxygenation parameters, including cerebral regional oxygen saturation (crSO2), splanchnic regional oxygen saturation (srSO2), the ratio of crSO2 to srSO2 (CSOR), cerebral fractionated tissue oxygen saturation (cFTOE) and splanchnic fractionated tissue oxygen saturation (sFTOE) will be measured immediately before PRBCT (baseline) and at the first, sixth, 12th, 24th, and 48th hours after PRBCT using near-infrared spectroscopy.
Dietary supplement: Enteral feeding
Enteral feeding will be withheld or continued in very low birthweight neonates during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation will be measured using near-infrared spectroscopy (NIRS) for 48 hours. Cerebral and splanchnic oxygenation parameters, including cerebral regional oxygen saturation (crSO2), splanchnic regional oxygen saturation (srSO2), the ratio of crSO2 to srSO2 (CSOR), cerebral fractionated tissue oxygen saturation (cFTOE) and splanchnic fractionated tissue oxygen saturation (sFTOE) will be measured immediately before PRBCT (baseline) and at the first, sixth, 12th, 24th, and 48th hours after PRBCT using near-infrared spectroscopy.
Other Names:
  • enteral nutrition
Active Comparator: Feeding restricted arm
Enteral feeding will be withhold during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation will be measured using near-infrared spectroscopy (NIRS) for 48 hours. Cerebral and splanchnic oxygenation parameters, including cerebral regional oxygen saturation (crSO2), splanchnic regional oxygen saturation (srSO2), the ratio of crSO2 to srSO2 (CSOR), cerebral fractionated tissue oxygen saturation (cFTOE) and splanchnic fractionated tissue oxygen saturation (sFTOE) will be measured immediately before PRBCT (baseline) and at the first, sixth, 12th, 24th, and 48th hours after PRBCT using near-infrared spectroscopy.
Dietary supplement: Enteral feeding
Enteral feeding will be withheld or continued in very low birthweight neonates during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation will be measured using near-infrared spectroscopy (NIRS) for 48 hours. Cerebral and splanchnic oxygenation parameters, including cerebral regional oxygen saturation (crSO2), splanchnic regional oxygen saturation (srSO2), the ratio of crSO2 to srSO2 (CSOR), cerebral fractionated tissue oxygen saturation (cFTOE) and splanchnic fractionated tissue oxygen saturation (sFTOE) will be measured immediately before PRBCT (baseline) and at the first, sixth, 12th, 24th, and 48th hours after PRBCT using near-infrared spectroscopy.
Other Names:
  • enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Splanchnic oxygenation
Time Frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
Monitoring regional splanchnic oxygenation (SrSO2) and splanchnic fractionated tissue oxygen saturation (sFTOE)
Prior to red blood cell transfusion to 48 hours following blood transfusion
Cerebral oxygenation
Time Frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
Monitoring Cerebral oxygenation parameters, including cerebral regional oxygen saturation (crSO2), cerebral fractionated tissue oxygen saturation (cFTOE)
Prior to red blood cell transfusion to 48 hours following blood transfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding intolerance and/or transfusion related necrotizing enterocolitis
Time Frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
To observe (if any) the signs and symptoms of a new-onset feeding intolerance and/or necrotizing enterocolitis for next 48 hours following the blood transfusion.
Prior to red blood cell transfusion to 48 hours following blood transfusion

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Hakan ONGUN, MD, Akdeniz university faculty of medicine department of pediatrics, division of neonatology

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 (Actual)

June 1, 2021

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK-737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient data (excluding patient name, ID and parental consent forms) will be shared

IPD Sharing Time Frame

November 2024 - November 2025

IPD Sharing Access Criteria

The datasets generated during and/or analysed during the current study will be available upon request from Hakan ONGUN

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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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