Clinical Trials Directory

Trials / Completed

CompletedNCT02347475

SMA Flow Patterns in Neonatal Transfusion

Impact of Red Cell Transfusion on Superior Mesenteric Artery Flow Patterns and Intestinal Oxygenation in Fed Preterm Neonates (SPARTAN: Sma PAttern Related to TrAnsfusion in Neonates)

Status
Completed
Phase
Study type
Observational
Enrollment
7 (actual)
Sponsor
University of Calgary · Academic / Other
Sex
All
Age
1 Day – 6 Months
Healthy volunteers
Not accepted

Summary

This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

Detailed description

Hypothesis: In preterm neonates the anticipated physiologic post-prandial increase in each SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants and/or in the presence of a PDA. Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial SMA flows changes before and after PRBC transfusion. Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured intestinal oxygenation parameters before and after PRBC transfusion.

Conditions

Interventions

TypeNameDescription
OTHERObservational StudyUltrasound and NIRS

Timeline

Start date
2015-01-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2015-01-27
Last updated
2018-05-03

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02347475. Inclusion in this directory is not an endorsement.