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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03643458
Other study ID # SO-2014-NIRS
Secondary ID 122/2012/U/Oss
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date June 30, 2014

Study information

Verified date September 2018
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Description:

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Study Design


Locations

Country Name City State
Italy Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital Bologna

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Incidence of gut complications Occurrence of necrotizing enterocolitis or feeding intolerance in infants undergone red blood cell transfusion 48 hours after transfusion
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