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

September 5, 2018 updated by: Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anemic preterm infants requiring red blood cell transfusion.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Transfused infants
Preterm infants undergone red blood cell transfusion during hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Enteral feed before red blood cell transfusion administration (3 hours)
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
Enteral feed after red blood cell transfusion administration (3 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of gut complications
Time Frame: 48 hours after transfusion
Occurrence of necrotizing enterocolitis or feeding intolerance in infants undergone red blood cell transfusion
48 hours after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Luigi Corvaglia, S.Orsola-Malpighi University Hospital, Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

June 30, 2014

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SO-2014-NIRS
  • 122/2012/U/Oss (Other Identifier: Ethic Committee of St. Orsola-Malpighi University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Necrotizing Enterocolitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe