- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01949896
Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Delaware
-
Newark, Delaware, Förenta staterna, 19713
- Christiana Care Health System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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. |
Infants in this group will be made NPO for a period of time surrounding the packed red blood cell transfusion.
|
|
Övrig: 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. |
Feedings will be continued in this group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pro-inflammatory cytokine response
Tidsram: 24 hours
|
Evaluate the pro-inflammatory cytokine response in both fed and NPO infants during a transfusion
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Andrew Ellefson, MD, Christiana Care Health Services
- Studierektor: David A Paul, MD, Christiana Care Health Services
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- DDD602270
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