SMA Flow Patterns in Neonatal Transfusion

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.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Prematurity (<34 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
Skin disruption precluding application of sensors

Treatment and study plan

observational study

Other

Ultrasound and NIRS

Primary outcomes

Post-prandial SMA flows changes before and after PRBC transfusion

Time frame: Just prior to transfusion until 48 hours post completion of transfusion

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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)

Acronym: SPARTAN

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jan 27, 2015
Registry last updated: May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed