An interventional study of Enteral feeding in Necrotizing Enterocolitis of Newborn, Feeding Intolerance and PreTerm Neonate, sponsored by Akdeniz University. Active, not recruiting at 1 site in Turkey. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Akdeniz University · Not applicable, Interventional, and Screening
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:
Participants will:
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 45 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
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Exclusion criteria:
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 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.
Also known as: enteral nutrition
Splanchnic oxygenation
Monitoring regional splanchnic oxygenation (SrSO2) and splanchnic fractionated tissue oxygen saturation (sFTOE)
Time frame: 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)
Time frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
Feeding intolerance and/or transfusion related necrotizing enterocolitis
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.
Time frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
Plan to share: Yes — Patient data (excluding patient name, ID and parental consent forms) will be shared
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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