Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

October 13, 2022 updated by: Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Infection and inflammation is related to increased encephalopathy of prematurities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Department of Pediatrics,Daping Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • preterm infants with encephalopathy

Exclusion Criteria:

  • refuse the participate in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: human gamma globulin
human gamma globulin for infants with encephalopathy of prematurities
Drug: human gamma globulin
human gamma globulin for preterm infants with encephalopathy of prematurities
Drug: non-human gamma globulin
Non-human gamma globulin for preterm infants with encephalopathy of prematurities
Active Comparator: non-human gamma globulin
non-human gamma globulin for infants with encephalopathy of prematurities
Drug: human gamma globulin
human gamma globulin for preterm infants with encephalopathy of prematurities
Drug: non-human gamma globulin
Non-human gamma globulin for preterm infants with encephalopathy of prematurities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
structural changes of brain injury
Time Frame: 100-days
MRI/ultrasound will be used to assess the structural severities of brain injury.
100-days
functional changes of brain injury
Time Frame: 100-days
Bayley score will be used to assess the functional severities of brain injury.
100-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVIG for encephalopathy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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