The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation

Necrotizing Enterocolitis Clinical Trial

Official title:

The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733718
• Other study ID #: MR-01022016
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2016
• Last updated: April 8, 2016
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2016
• Source: Marmara University
• Contact: Hülya Selva Bilgen, MD
• Phone: 0905332612124
• Email: hülya.bilgen[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Device:
• NIRS (near-infrared spectroscopy)
mesenteric oxygenisation measurement

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bailey SM, Hendricks-Muñoz 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. — View 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.1537-2995.2009.0 — View 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. — View 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 2

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)	number of participants that has low mesenteric oxygenisation after transfusion	48 hours	Yes
Secondary	Feeding intolerance (number of participants that has feeding intolerance after transfusion)	number of participants that has feeding intolerance after transfusion	starting with transfusion until discharge, assessed up to 12 weeks	Yes
Secondary	NEC (number of participants that has occurred transfusion related NEC)	number of participants that has occurred transfusion related NEC	starting with transfusion until discharge, assessed up to 12 weeks	Yes