Necrotizing EnterocolitisNCT02733718
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
A study testing NIRS (near-infrared spectroscopy) in people with Necrotizing Enterocolitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- NIRS (near-infrared spectroscopy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2015to Sep 2017
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prematurity (<32 completed weeks of gestation at birth)
- Need for PRBC transfusion
- Feeding at least 30ml/kg/day at the time of transfusion
Who cannot join
- Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
- Infants receiving continuous feeds or less than 30ml/kg/day
- Major congenital or chromosomal abnormalities or infants unlikely to survive
- Intraventricular hemorrhage >Grade 3
- Hemodynamically significant patent ductus arteriosus
- Infants requiring vasopressor support
- Skin disruption precluding application of sensors
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul
Hülya Selva Bilgen, professor, 0905332612124, hülya.bilgen@gmail.com
About this study
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.
Read the detailed description
Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard.
"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.
Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.
Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.
Group 3: The same feeding volume will be continued without decreasing or stopping.
Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline.
The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- NIRS (near-infrared spectroscopy)
- Keywords
- Necrotizing enterocolitis, Transfusion, Mesenteric Oxygenisation
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS (near-infrared spectroscopy)Device
mesenteric oxygenisation measurement
| Study group | Role | What they receive |
|---|---|---|
| Group 1: no enteral feeding | Other | intervention: NIRS (near-infrared spectroscopy) Receives: Device: NIRS (near-infrared spectroscopy) |
| Group 2: Feeding is reduced by %50 | Other | intervention: NIRS (near-infrared spectroscopy) Receives: Device: NIRS (near-infrared spectroscopy) |
| Group 3: Feeding will be continued | Other | intervention: NIRS (near-infrared spectroscopy) Receives: Device: NIRS (near-infrared spectroscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
number of participants that has low mesenteric oxygenisation after transfusion
Measured: 48 hours
Secondary outcomes (2)
Feeding intolerance (number of participants that has feeding intolerance after transfusion)
number of participants that has feeding intolerance after transfusion
Measured: starting with transfusion until discharge, assessed up to 12 weeks
NEC (number of participants that has occurred transfusion related NEC)
number of participants that has occurred transfusion related NEC
Measured: starting with transfusion until discharge, assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hülya Selva Bilgen, MD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733718
- Sponsor's protocol ID
- MR-01022016
- Status last verified
- Apr 2016
- First submitted
- 28 Feb 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Marin T. Mesenteric perfusion pattern changes as the result of packed red blood cell transfusions in preterm infants. (Doctoral Dissertation). 2012. Retrieved from Emory Electronic Theses and Dissertations Repository. UMI number 3522333. [cited 2013 Feb 20]
Marin T, Moore J, Kosmetatos N, Roback JD, Weiss P, Higgins M, McCauley L, Strickland OL, Josephson CD. Red blood cell transfusion-related necrotizing enterocolitis in very-low-birthweight infants: a near-infrared spectroscopy investigation. Transfusion. 2013 Nov;53(11):2650-8. doi: 10.1111/trf.12158. Epub 2013 Mar 11.
PubMed 23480548Bailey SM, Hendricks-Munoz KD, Mally P. Splanchnic-cerebral oxygenation ratio as a marker of preterm infant blood transfusion needs. Transfusion. 2012 Feb;52(2):252-60. doi: 10.1111/j.1537-2995.2011.03263.x. Epub 2011 Jul 25.
PubMed 21790634Stritzke AI, Smyth J, Synnes A, Lee SK, Shah PS. Transfusion-associated necrotising enterocolitis in neonates. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F10-4. doi: 10.1136/fetalneonatal-2011-301282. Epub 2012 Mar 23.
PubMed 22447991Christensen RD, Lambert DK, Henry E, Wiedmeier SE, Snow GL, Baer VL, Gerday E, Ilstrup S, Pysher TJ. Is "transfusion-associated necrotizing enterocolitis" an authentic pathogenic entity? Transfusion. 2010 May;50(5):1106-12. doi: 10.1111/j.1537-2995.2009.02542.x. Epub 2009 Dec 29.
PubMed 20051059
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
- ClinicalTrials.gov ID
- NCT02733718
- Acronym / sponsor ID
- MR-01022016
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing enterocolitis, Transfusion, Mesenteric Oxygenisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- 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 study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.
Detailed description
Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard.
"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.
Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.
Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.
Group 3: The same feeding volume will be continued without decreasing or stopping.
Groups will be determined with randomization. It was targeted to be at least twenty infants in each group. In all patients, mesenteric oxygenation will be compared before-during and after blood transfusion. Mesenteric oxygenation will be measured with Near Infrared Spectroscopy (NIRS), that is a non-invasive NIRS conducted technology. Cerebral oxygenation and peripheral oxygen saturations will be measured at the same timeline.
The investigators primary aim is to show the best method of feeding during transfusion that causes less feeding intolerance and NEC. The secondary outcomes will be the risk factors associated with feeding intolerance and NEC during PRBC transfusion, in premature babies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: no enteral feeding | Other | Device: NIRS (near-infrared spectroscopy)intervention: NIRS (near-infrared spectroscopy) |
| Group 2: Feeding is reduced by %50 | Other | Device: NIRS (near-infrared spectroscopy)intervention: NIRS (near-infrared spectroscopy) |
| Group 3: Feeding will be continued | Other | Device: NIRS (near-infrared spectroscopy)intervention: NIRS (near-infrared spectroscopy) |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Prematurity (<32 completed weeks of gestation at birth)
- Need for PRBC transfusion
- Feeding at least 30ml/kg/day at the time of transfusion
Key exclusion criteria (7 listed)
- Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
- Infants receiving continuous feeds or less than 30ml/kg/day
- Major congenital or chromosomal abnormalities or infants unlikely to survive
- Intraventricular hemorrhage >Grade 3
- Hemodynamically significant patent ductus arteriosus
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 |
|---|---|---|
| NIRS (near-infrared spectroscopy)mesenteric oxygenisation measurement | Device | Group 1: no enteral feeding, Group 2: Feeding is reduced by %50, Group 3: Feeding will be continued |
Primary outcome
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
Time frame: 48 hours
number of participants that has low mesenteric oxygenisation after transfusion
2 secondary outcomes
Feeding intolerance (number of participants that has feeding intolerance after transfusion)
Time frame: starting with transfusion until discharge, assessed up to 12 weeks
NEC (number of participants that has occurred transfusion related NEC)
Time frame: starting with transfusion until discharge, assessed up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Results publicationMarin T. Mesenteric perfusion pattern changes as the result of packed red blood cell transfusions in preterm infants. (Doctoral Dissertation). 2012. Retrieved from Emory Electronic Theses and Dissertations Repository. UMI number 3522333. [cited 2013 Feb 20]
- Results publication: PubMed 23480548Marin T, Moore J, Kosmetatos N, Roback JD, Weiss P, Higgins M, McCauley L, Strickland OL, Josephson CD. Red blood cell transfusion-related necrotizing enterocolitis in very-low-birthweight infants: a near-infrared spectroscopy investigation. Transfusion. 2013 Nov;53(11):2650-8. doi: 10.1111/trf.12158. Epub 2013 Mar 11.
- Results publication: PubMed 21790634Bailey SM, Hendricks-Munoz KD, Mally P. Splanchnic-cerebral oxygenation ratio as a marker of preterm infant blood transfusion needs. Transfusion. 2012 Feb;52(2):252-60. doi: 10.1111/j.1537-2995.2011.03263.x. Epub 2011 Jul 25.
- Results publication: PubMed 22447991Stritzke AI, Smyth J, Synnes A, Lee SK, Shah PS. Transfusion-associated necrotising enterocolitis in neonates. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F10-4. doi: 10.1136/fetalneonatal-2011-301282. Epub 2012 Mar 23.
- Results publication: PubMed 20051059Christensen RD, Lambert DK, Henry E, Wiedmeier SE, Snow GL, Baer VL, Gerday E, Ilstrup S, Pysher TJ. Is "transfusion-associated necrotizing enterocolitis" an authentic pathogenic entity? Transfusion. 2010 May;50(5):1106-12. doi: 10.1111/j.1537-2995.2009.02542.x. Epub 2009 Dec 29.
- Individual participant dataSharing planned: Undecided
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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.
Hülya Selva Bilgen, MD study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS (near-infrared spectroscopy) in people with Necrotizing Enterocolitis, run by Marmara 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 3 inclusion and 7 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 11 Apr 2016. 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?
Contact Hülya Selva Bilgen, MD (0905332612124, hülya.bilgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733718, which also lists 5 linked publications.
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 11 Apr 2016.