Blood Transfusion ComplicationNIRS_RBCNCT03643458
Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
An observational study of Blood Transfusion Complication and Necrotizing Enterocolitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Blood Transfusion Complication, Necrotizing Enterocolitis, Enteral Feeding Intolerance
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2013to 30 Jun 2014
- Phase
- Observational
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Anemic preterm infants requiring red blood cell transfusion.
Who may be able to join
- gestational age <32 weeks or birth weight <1500 g
- need for red blood cell transfusion according to national guidelines
Who cannot join
- hemodynamic instability
- Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion
Trial locations and contacts
1 site in 1 country.
Italy1 site
Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital
Bologna, 40138
About this study
Official title: Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion; a possible role for these findings in increasing the risk for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Read the detailed description
Premature neonates are among the most transfused population, but the risks and benefits of this procedure remain unclear. Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most common and feared gastrointestinal complications of prematurity. Several observational studies have tried to demonstrate this causal correlation, defining the so-called transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion. This evidence, which has been hypothesized to play a role on the risk of TANEC development, has significantly raised the attention over the feeding plans during and after RBC transfusion.
To date, splanchnic oxygenation response to feeds before and after transfusion has not been investigated, but could bring useful information to understand the splanchnic hemodynamic changes associated to RBC transfusion.
Therefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Enrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2) oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal sensors will be placed in the central region of the forehead and the below the umbilicus, respectively.
The study monitoring includes the following phases:
- Phase 1 (0-3 hours): pre-transfusion feed and related post-prandial period
- Phase 2 (4-9 hours): RBC transfusion (10 ml/kg),administered over 3 hours, following which feeds are hold for 3 hours.
- Phase 3 (10-12 hours): post-transfusion feed and related post-prandial period.
CrSO2 and SrSO2 patterns before and after transfusion and the related changes from baseline values will be analyzed. SCOR (CrSO2/SrSO2 ratio) patterns will be also calculated and analyzed. IBM SPSS Statistics (Statistical Package for the Social Sciences, SPSS Inc., IBM, Armonk, NY) will be used for statistical analysis. If any infant develops TANEC after transfusion, the related patterns will be evaluated and analyzed separately.
- Conditions
- Blood Transfusion Complication, Necrotizing Enterocolitis, Enteral Feeding Intolerance, Preterm Infant
- Keywords
- NIRS, TANEC, splanchnic oxygenation, enteral feeding, preterm infants
- Medical subject headings
- Transfusion Reaction, Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfused infants | Preterm infants undergone red blood cell transfusion during hospital stay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-transfusion splanchnic oxygenation pattern
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
Measured: Enteral feed before red blood cell transfusion administration (3 hours)
Post-transfusion splanchnic oxygenation pattern
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
Measured: Enteral feed after red blood cell transfusion administration (3 hours)
Secondary outcomes (1)
Incidence of gut complications
Occurrence of necrotizing enterocolitis or feeding intolerance in infants undergone red blood cell transfusion
Measured: 48 hours after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jun 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Blood Transfusion ComplicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Luigi Corvaglia, Principal investigator, S.Orsola-Malpighi University Hospital, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643458
- Sponsor's protocol ID
- SO-2014-NIRS
- Other IDs
- 122/2012/U/Oss
- Acronym
- NIRS_RBC
- Status last verified
- Sep 2018
- First submitted
- 21 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 23480548White L, Said M, Rais-Bahrami K. Monitoring mesenteric tissue oxygenation with near-infrared spectroscopy during packed red blood cell transfusion in preterm infants. J Neonatal Perinatal Med. 2015;8(2):157-63. doi: 10.3233/NPM-15814090.
PubMed 26410441Bailey SM, Hendricks-Munoz KD, Mally PV. Variability in splanchnic tissue oxygenation during preterm red blood cell transfusion given for symptomatic anaemia may reveal a potential mechanism of transfusion-related acute gut injury. Blood Transfus. 2015 Jul;13(3):429-34. doi: 10.2450/2015.0212-14. Epub 2015 Jan 30.
PubMed 25761320Marin T, Josephson CD, Kosmetatos N, Higgins M, Moore JE. Feeding preterm infants during red blood cell transfusion is associated with a decline in postprandial mesenteric oxygenation. J Pediatr. 2014 Sep;165(3):464-71.e1. doi: 10.1016/j.jpeds.2014.05.009. Epub 2014 Jun 16.
PubMed 24948351Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.
PubMed 19021097Banerjee J, Leung TS, Aladangady N. Effect of blood transfusion on intestinal blood flow and oxygenation in extremely preterm infants during first week of life. Transfusion. 2016 Apr;56(4):808-15. doi: 10.1111/trf.13434. Epub 2015 Dec 8.
PubMed 26643925Banerjee J, Leung TS, Aladangady N. Blood transfusion in preterm infants improves intestinal tissue oxygenation without alteration in blood flow. Vox Sang. 2016 Nov;111(4):399-408. doi: 10.1111/vox.12436. Epub 2016 Aug 10.
PubMed 27509230
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants
- ClinicalTrials.gov ID
- NCT03643458
- Acronym / sponsor ID
- NIRS_RBC / SO-2014-NIRS
- Conditions
- Blood Transfusion Complication, Necrotizing Enterocolitis, Enteral Feeding Intolerance, Preterm Infant
- Keywords
- NIRS, TANEC, splanchnic oxygenation, enteral feeding, preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 22 Aug 2018 (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.
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion; a possible role for these findings in increasing the risk for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Detailed description
Premature neonates are among the most transfused population, but the risks and benefits of this procedure remain unclear. Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most common and feared gastrointestinal complications of prematurity. Several observational studies have tried to demonstrate this causal correlation, defining the so-called transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion. This evidence, which has been hypothesized to play a role on the risk of TANEC development, has significantly raised the attention over the feeding plans during and after RBC transfusion.
To date, splanchnic oxygenation response to feeds before and after transfusion has not been investigated, but could bring useful information to understand the splanchnic hemodynamic changes associated to RBC transfusion.
Therefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Enrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2) oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal sensors will be placed in the central region of the forehead and the below the umbilicus, respectively.
The study monitoring includes the following phases:
- Phase 1 (0-3 hours): pre-transfusion feed and related post-prandial period
- Phase 2 (4-9 hours): RBC transfusion (10 ml/kg),administered over 3 hours, following which feeds are hold for 3 hours.
- Phase 3 (10-12 hours): post-transfusion feed and related post-prandial period.
CrSO2 and SrSO2 patterns before and after transfusion and the related changes from baseline values will be analyzed. SCOR (CrSO2/SrSO2 ratio) patterns will be also calculated and analyzed. IBM SPSS Statistics (Statistical Package for the Social Sciences, SPSS Inc., IBM, Armonk, NY) will be used for statistical analysis. If any infant develops TANEC after transfusion, the related patterns will be evaluated and analyzed separately.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfused infants | – | –Preterm infants undergone red blood cell transfusion during hospital stay. |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Anemic preterm infants requiring red blood cell transfusion.
Key inclusion criteria (2 listed)
- gestational age <32 weeks or birth weight <1500 g
- need for red blood cell transfusion according to national guidelines
Key exclusion criteria (2 listed)
- hemodynamic instability
- Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-transfusion splanchnic oxygenation pattern
Time frame: Enteral feed before red blood cell transfusion administration (3 hours)
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
Post-transfusion splanchnic oxygenation pattern
Time frame: Enteral feed after red blood cell transfusion administration (3 hours)
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
1 secondary outcome
Incidence of gut complications
Time frame: 48 hours after transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: 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.
- Background: PubMed 26410441White L, Said M, Rais-Bahrami K. Monitoring mesenteric tissue oxygenation with near-infrared spectroscopy during packed red blood cell transfusion in preterm infants. J Neonatal Perinatal Med. 2015;8(2):157-63. doi: 10.3233/NPM-15814090.
- Background: PubMed 25761320Bailey SM, Hendricks-Munoz KD, Mally PV. Variability in splanchnic tissue oxygenation during preterm red blood cell transfusion given for symptomatic anaemia may reveal a potential mechanism of transfusion-related acute gut injury. Blood Transfus. 2015 Jul;13(3):429-34. doi: 10.2450/2015.0212-14. Epub 2015 Jan 30.
- Background: PubMed 24948351Marin T, Josephson CD, Kosmetatos N, Higgins M, Moore JE. Feeding preterm infants during red blood cell transfusion is associated with a decline in postprandial mesenteric oxygenation. J Pediatr. 2014 Sep;165(3):464-71.e1. doi: 10.1016/j.jpeds.2014.05.009. Epub 2014 Jun 16.
- Background: PubMed 19021097Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.
- Background: PubMed 26643925Banerjee J, Leung TS, Aladangady N. Effect of blood transfusion on intestinal blood flow and oxygenation in extremely preterm infants during first week of life. Transfusion. 2016 Apr;56(4):808-15. doi: 10.1111/trf.13434. Epub 2015 Dec 8.
- Background: PubMed 27509230Banerjee J, Leung TS, Aladangady N. Blood transfusion in preterm infants improves intestinal tissue oxygenation without alteration in blood flow. Vox Sang. 2016 Nov;111(4):399-408. doi: 10.1111/vox.12436. Epub 2016 Aug 10.
- Individual participant dataSharing planned: No
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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.
Luigi Corvaglia principal investigator
S.Orsola-Malpighi University Hospital, Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Transfusion Complication and Necrotizing Enterocolitis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Sep 2018. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre-transfusion splanchnic oxygenation pattern (time frame: Enteral feed before red blood cell transfusion administration (3 hours)). 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?
On the ClinicalTrials.gov record for NCT03643458, which also lists 7 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 7 Sep 2018.