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

Christiana Care Health Services

Status: Terminated

Conditions: Transfusions

Treatments: Other: Control group: continue feedings; Other: NPO

Study type: Interventional

Funder types: Other

Identifiers

NCT01949896

DDD602270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 3 days to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Intervention: NPO

Other group

Description:

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.

Treatment:

Other: NPO

Control: Continue feedings

Other group

Description:

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.

Treatment:

Other: Control group: continue feedings