Necrotizing Enterocolitis of NewbornTANECNCT06632314
Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants
A study testing Enteral feeding in people with Necrotizing Enterocolitis of Newborn and Feeding Intolerance, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Necrotizing Enterocolitis of Newborn, Feeding Intolerance, PreTerm Neonate
- What is being tested?
- Enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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,
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- hemodynamically significant patent ductus arteriosus
- history of abdominal surgery,
- complex congenital anomalies involving gastrointestinal tract and cardiovascular system,
- missing data,
- parental reluctance to consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Medicine
Antalya, Konyaalti, 07000
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Necrotizing Enterocolitis of Newborn, Feeding Intolerance, PreTerm Neonate, Transfusion Related Complications
- Being tested
- Enteral feeding
- Keywords
- enteral feeding, splanchnic oxygenation, preterm neonate, transfusion related necrotizing enterocolitis, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral feedingDietary supplement
Also called enteral nutrition
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Splanchnic oxygenation
Monitoring regional splanchnic oxygenation (SrSO2) and splanchnic fractionated tissue oxygen saturation (sFTOE)
Measured: 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)
Measured: Prior to red blood cell transfusion to 48 hours following blood transfusion
Secondary outcomes (1)
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.
Measured: Prior to red blood cell transfusion to 48 hours following blood transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jun 2021
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis of NewbornStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Ongun, Akdeniz University
- Investigators
- Hakan ONGUN, MD, Principal investigator, Akdeniz university faculty of medicine department of pediatrics, division of neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632314
- Sponsor's protocol ID
- KAEK-737
- Acronym
- TANEC
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient data (excluding patient name, ID and parental consent forms) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enteral Feeding on Cerebral and Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06632314
- Acronym / sponsor ID
- TANEC / KAEK-737
- Conditions
- Necrotizing Enterocolitis of Newborn, Feeding Intolerance, PreTerm Neonate, Transfusion Related Complications
- Keywords
- enteral feeding, splanchnic oxygenation, preterm neonate, transfusion related necrotizing enterocolitis, NIRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding continued arm | Active comparator | Dietary Supplement: Enteral feedingEnteral 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. |
| Feeding restricted arm | Active comparator | Dietary Supplement: Enteral feedingEnteral 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. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral feedingAlso: enteral nutritionEnteral 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. | Dietary supplement | Feeding continued arm, Feeding restricted arm |
Primary outcome
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)
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)
1 secondary outcome
Feeding intolerance and/or transfusion related necrotizing enterocolitis
Time frame: Prior to red blood cell transfusion to 48 hours following blood transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Yes. Patient data (excluding patient name, ID and parental consent forms) will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan ONGUN, MD principal investigator
Akdeniz university faculty of medicine department of pediatrics, division of neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral feeding in people with Necrotizing Enterocolitis of Newborn and Feeding Intolerance, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splanchnic oxygenation (time frame: Prior to red blood cell transfusion to 48 hours following blood transfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.