NCT02347475

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

January 15, 2015

Last Update Submit

May 1, 2018

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

  • Post-prandial SMA flows changes before and after PRBC transfusion

    Just prior to transfusion until 48 hours post completion of transfusion

Interventions

Observational StudyOTHER

Ultrasound and NIRS

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Prematurity (\<34 completed weeks of gestation at birth) Need for PRBC transfusion

You may qualify if:

  • Prematurity (\<34 completed weeks of gestation at birth)
  • Need for PRBC transfusion
  • Feeding at least 30ml/kg/day at the time of transfusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Observation

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Amelie Stritzke, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 27, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

CA(1)