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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Primary Purpose

Preterm Infants

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
human gamma globulin
non-human gamma globulin
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants with encephalopathy

Exclusion Criteria:

  • refuse the participate in the trial

Sites / Locations

  • Department of Pediatrics,Daping HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

human gamma globulin

non-human gamma globulin

Arm Description

human gamma globulin for infants with encephalopathy of prematurities

non-human gamma globulin for infants with encephalopathy of prematurities

Outcomes

Primary Outcome Measures

structural changes of brain injury
MRI/ultrasound will be used to assess the structural severities of brain injury.
functional changes of brain injury
Bayley score will be used to assess the functional severities of brain injury.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2016
Last Updated
October 13, 2022
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02822027
Brief Title
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Official Title
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Infection and inflammation is related to increased encephalopathy of prematurities.
Detailed Description
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
human gamma globulin
Arm Type
Experimental
Arm Description
human gamma globulin for infants with encephalopathy of prematurities
Arm Title
non-human gamma globulin
Arm Type
Active Comparator
Arm Description
non-human gamma globulin for infants with encephalopathy of prematurities
Intervention Type
Drug
Intervention Name(s)
human gamma globulin
Intervention Description
human gamma globulin for preterm infants with encephalopathy of prematurities
Intervention Type
Drug
Intervention Name(s)
non-human gamma globulin
Intervention Description
Non-human gamma globulin for preterm infants with encephalopathy of prematurities
Primary Outcome Measure Information:
Title
structural changes of brain injury
Description
MRI/ultrasound will be used to assess the structural severities of brain injury.
Time Frame
100-days
Title
functional changes of brain injury
Description
Bayley score will be used to assess the functional severities of brain injury.
Time Frame
100-days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infants with encephalopathy Exclusion Criteria: refuse the participate in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Fang, MD
Phone
8613883559467
Email
476679422@qq.com
Facility Information:
Facility Name
Department of Pediatrics,Daping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Fang, MD
Phone
8613883559467
Email
476679422@qq.com

12. IPD Sharing Statement

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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

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