Impact of Feeding on Pro-Inflammatory Cytokine Response i... | NCT01949896

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

NCT01949896

Sponsor

Christiana Care Health Services

Status

Terminated

Last Update Posted

Mar 11, 2016Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Transfusions

Interventions

NPO
Control group: continue feedings

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study is being closed due to insufficient patient population for enrollment.

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Sep 21, 2013

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2016

Last Update Posted Date

Mar 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Ellefson, MD / Neonatal Fellow, Christiana Care Health ServicesPrincipal Investigator

Lead Sponsor

Christiana Care Health ServicesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NPO	Other	Infants in this group will be made NPO for a period of time surrounding the packed red blood cell transfusion.	Intervention: NPO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Ellefson, MD	Christiana Care Health Services	Principal Investigator
David A Paul, MD	Christiana Care Health Services	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health System		Newark	Delaware	19713	United States

Condition Browse Module

MeSH Terms

ID	Term
D020345	Enterocolitis, Necrotizing

Ancestor Terms

ID	Term
D004760	Enterocolitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided