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

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.

Study Overview

• Status: Terminated
• Conditions: Transfusions
• Intervention / Treatment: Other: NPO; Other: Control group: continue feedings

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: NPO; Infants in this group will be made NPO for a period of time surrounding the packed red blood cell transfusion.
Other: 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.	Other: Control group: continue feedings; Feedings will be continued in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory cytokine response	Evaluate the pro-inflammatory cytokine response in both fed and NPO infants during a transfusion	24 hours

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: Andrew Ellefson, MD, Christiana Care Health Services; Study Director: David A Paul, MD, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 21, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Necrotizing enterocolitis; Packed red blood cell transfusion; Pro inflammatory cytokine
• Other Study ID Numbers: DDD602270