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

NCT06632314 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-09

No results posted yet for this study

Summary

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

Conditions

  • Necrotizing Enterocolitis of Newborn
  • Feeding Intolerance
  • PreTerm Neonate
  • Transfusion Related Complications

Interventions

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.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • Hakan ONGUN, MD · Akdeniz university faculty of medicine department of pediatrics, division of neonatology

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-10-30
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632314 on ClinicalTrials.gov