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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Recently many publications have indicated a potential temporal association between packed red blood cell (PRBC) transfusion and the development of NEC in neonates. Although, to date, there is no conclusive evidence indicating a causal role of PRBC transfusion on the development of NEC. Given the growing body of data that support the association of PRBC transfusions and NEC, a common clinical dilemma arises with regard to feeding infants during a blood transfusion. Additionally, it is thought that increased immunomodulation may be exacerbated by any other pro-inflammatory process or insult; thereby leading to a rapidly increasing cascade of pro-inflammatory cytokines which may ultimately lead to gut inflammation and NEC.

Prior to a non-urgent PRBC transfusion, subjects will be randomized to either the NPO group or fed group of patients. The intervention will be the placement of a subject in the NPO group. Subjects will be made NPO for a total of 24 hours around the time of the PRBC transfusion. 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

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Transfusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention: NPO

Infants in this group will be made NPO approximately 4 hours prior to receiving a blood transfusion and will remain NPO until approximately 24 hours after the blood transfusion.

Pro-inflammatory cytokine response will be monitored at 3 times points.

Group Type OTHER

NPO

Intervention Type OTHER

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

Control: Continue feedings

Infants in this group will be allowed to continue feedings during the transfusion at the discretion of the medical team.

Pro-inflammatory cytokine response will be monitored at 3 times points.

Group Type OTHER

Control group: continue feedings

Intervention Type OTHER

Feedings will be continued in this group.

Interventions

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NPO

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

Intervention Type OTHER

Control group: continue feedings

Feedings will be continued in this group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants born \< 31 weeks gestational age
* Between 3 and 7 days old at time of consent

Exclusion Criteria

* Infants with multiple congenital anomalies
* Infant with suspected/confirmed genetic anomalies
* Infant with suspected/confirmed congenital immune deficiencies

Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes