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

NCT01949896 | Terminated

• 1 other identifier: DDD602270
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pro inflammatory cytokine; Necrotizing enterocolitis; Packed red blood cell transfusion

Outcome Measures

Primary Outcomes (1)

• Pro-inflammatory cytokine response

  Evaluate the pro-inflammatory cytokine response in both fed and NPO infants during a transfusion

  24 hours

Study Arms (2)

Intervention: NPO

OTHER

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

Control: Continue feedings

OTHER

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

Interventions

NPO OTHER

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

Intervention: NPO

Control group: continue feedings OTHER

Feedings will be continued in this group.

Control: Continue feedings

Eligibility Criteria

• Age: 3 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Andrew Ellefson, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

• David A Paul, MD

  Christiana Care Health Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD / Neonatal Fellow

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)