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

NCT06632314 | Active Not Recruiting DMC

• 1 other identifier: KAEK-737
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

enteral feeding; splanchnic oxygenation; preterm neonate; transfusion related necrotizing enterocolitis; NIRS

Outcome Measures

Primary Outcomes (2)

• Splanchnic oxygenation

  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

  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 Outcomes (1)

• Feeding intolerance and/or transfusion related necrotizing enterocolitis

  Prior to red blood cell transfusion to 48 hours following blood transfusion

Study Arms (2)

Feeding continued arm

ACTIVE COMPARATOR

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

Feeding restricted arm

ACTIVE COMPARATOR

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

Interventions

Enteral feeding DIETARY_SUPPLEMENT

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.

Also known as: enteral nutrition

Feeding continued arm; Feeding restricted arm

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Medicine

Antalya, Konyaalti, 07000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Hakan ONGUN, MD

  Akdeniz university faculty of medicine department of pediatrics, division of neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in neonatology

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: June 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: November 2024 - November 2025
• Access Criteria: The datasets generated during and/or analysed during the current study will be available upon request from Hakan ONGUN

Locations

TU (1)