The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
Primary Purpose
Necrotizing Enterocolitis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NIRS (near-infrared spectroscopy)
Sponsored by
About this trial
This is an interventional screening trial for Necrotizing Enterocolitis focused on measuring Necrotizing enterocolitis, Transfusion, Mesenteric Oxygenisation
Eligibility Criteria
Inclusion Criteria:
- Prematurity (<32 completed weeks of gestation at birth)
- Need for PRBC transfusion
- Feeding at least 30ml/kg/day at the time of transfusion
Exclusion Criteria:
- 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
Sites / Locations
- Marmara University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Group 1: no enteral feeding
Group 2: Feeding is reduced by %50
Group 3: Feeding will be continued
Arm Description
intervention: NIRS (near-infrared spectroscopy)
intervention: NIRS (near-infrared spectroscopy)
intervention: NIRS (near-infrared spectroscopy)
Outcomes
Primary Outcome Measures
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
number of participants that has low mesenteric oxygenisation after transfusion
Secondary Outcome Measures
Feeding intolerance (number of participants that has feeding intolerance after transfusion)
number of participants that has feeding intolerance after transfusion
NEC (number of participants that has occurred transfusion related NEC)
number of participants that has occurred transfusion related NEC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02733718
Brief Title
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
Official Title
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
Necrotizing enterocolitis, Transfusion, Mesenteric Oxygenisation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: no enteral feeding
Arm Type
Other
Arm Description
intervention: NIRS (near-infrared spectroscopy)
Arm Title
Group 2: Feeding is reduced by %50
Arm Type
Other
Arm Description
intervention: NIRS (near-infrared spectroscopy)
Arm Title
Group 3: Feeding will be continued
Arm Type
Other
Arm Description
intervention: NIRS (near-infrared spectroscopy)
Intervention Type
Device
Intervention Name(s)
NIRS (near-infrared spectroscopy)
Intervention Description
mesenteric oxygenisation measurement
Primary Outcome Measure Information:
Title
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
Description
number of participants that has low mesenteric oxygenisation after transfusion
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Feeding intolerance (number of participants that has feeding intolerance after transfusion)
Description
number of participants that has feeding intolerance after transfusion
Time Frame
starting with transfusion until discharge, assessed up to 12 weeks
Title
NEC (number of participants that has occurred transfusion related NEC)
Description
number of participants that has occurred transfusion related NEC
Time Frame
starting with transfusion until discharge, assessed up to 12 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prematurity (<32 completed weeks of gestation at birth)
Need for PRBC transfusion
Feeding at least 30ml/kg/day at the time of transfusion
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hülya Selva Bilgen, MD
Phone
0905332612124
Email
hülya.bilgen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevgi Aslan, MD
Phone
0905545497372
Email
sevgi.asln@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hülya Selva Bilgen, MD
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University School of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hülya Selva Bilgen, professor
Phone
0905332612124
Email
hülya.bilgen@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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]
Results Reference
result
PubMed Identifier
23480548
Citation
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.
Results Reference
result
PubMed Identifier
21790634
Citation
Bailey 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 Reference
result
PubMed Identifier
22447991
Citation
Stritzke 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 Reference
result
PubMed Identifier
20051059
Citation
Christensen 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.
Results Reference
result
Learn more about this trial
The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
We'll reach out to this number within 24 hrs