Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion

NCT03643458 | Completed

• 2 other identifiers: SO-2014-NIRS122/2012/U/Oss
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Blood Transfusion Complication; Necrotizing Enterocolitis; Enteral Feeding Intolerance; Preterm Infant

Keywords

NIRS; TANEC; splanchnic oxygenation; enteral feeding; preterm infants

Outcome Measures

Primary Outcomes (2)

• Pre-transfusion splanchnic oxygenation pattern

  Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value

  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

  Enteral feed after red blood cell transfusion administration (3 hours)

Secondary Outcomes (1)

• Incidence of gut complications

  48 hours after transfusion

Study Arms (1)

Transfused infants

Preterm infants undergone red blood cell transfusion during hospital stay.

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Anemic preterm infants requiring red blood cell transfusion.

You may qualify if:

• gestational age \<32 weeks or birth weight \<1500 g
• need for red blood cell transfusion according to national guidelines

You may not qualify if:

• hemodynamic instability
• Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Related Publications (7)

• 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.

  PMID: 23480548 BACKGROUND

• White 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.

  PMID: 26410441 BACKGROUND

• Bailey 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.

  PMID: 25761320 BACKGROUND

• Marin 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.

  PMID: 24948351 BACKGROUND

• Krimmel 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.

  PMID: 19021097 BACKGROUND

• Banerjee 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.

  PMID: 26643925 BACKGROUND

• Banerjee 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.

  PMID: 27509230 BACKGROUND

MeSH Terms

Conditions

Transfusion Reaction; Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Luigi Corvaglia

  S.Orsola-Malpighi University Hospital, Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: June 1, 2013
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)