The Relationship Between Erythrocyte Transfusion and Nutr... | NCT04083638

Studies
The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants

NCT04083638

Sponsor

Dr. Behcet Uz Children's Hospital

Status

Unknown status

Last Update Posted

Sep 10, 2019Actual

Enrollment

81Estimated

Phase

Not provided

Conditions

Necrotizing Enterocolitis of Newborn

Interventions

IFAB

Countries

Turkey (Türkiye)

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Sep 6, 2019

First Submission Date that Met QC Criteria

Sep 6, 2019

First Posted Date

Sep 10, 2019Actual

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

Sep 6, 2019

Last Update Posted Date

Sep 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Senem Alkan Özdemir, MD, Associate Professor of Neonatology, Dr. Behcet Uz Children's HospitalPrincipal Investigator

Lead Sponsor

Dr. Behcet Uz Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Control group	Diagnostic Test: IFAB
Group 2		Feeding will not stop during the transfusion	Diagnostic Test: IFAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IFAB	Diagnostic Test	Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
necrotizing enterocolitis		0-48 hours after tx
Mortality	If all babies die after tx study will be finished	0-24 hour after tx

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

<32 gestational week and/or <1500 g birth weight

Exclusion Criteria:

Major congenital anomalies, hemodynamic instability

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Preterm infants

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Senem A Özdemir, MD	Contact	05327614670		drsenemalkan@yahoo.com
Şebnem A Çalkavur, MD	Contact	05327614670		sebnemcalkavur@yahoo.com

Overall Officials

Name	Affiliation	Role
Rüya Çolak, MD	Behcet Uz Children's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Behçet Uz Children's Hospital	Recruiting	İzmirli	İzmir	35210	Turkey (Türkiye)