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Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion

NCT01949896 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-03-11

No results posted yet for this study

Summary

Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds or continuing feeds. The intervention group will be the placement of a subject in the NPO group. Subjects in the intervention group will have their feedings stopped for a total of 24 hours around the time of the PRBC transfusion. These infants will be given intravenous nutrition during the period of time that they will not be fed. During the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.

Conditions

  • Transfusions

Interventions

OTHER

NPO

Infants in this group will be made NPO for a period of time surrounding the packed red blood cell transfusion.

OTHER

Control group: continue feedings

Feedings will be continued in this group.

Sponsors & Collaborators

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Andrew Ellefson, MD · Christiana Care Health Services

  • David A Paul, MD · Christiana Care Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949896 on ClinicalTrials.gov