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NCT02822027 Clinical Trial

Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Preterm Infants Clinical Trial

Official title:
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02822027
Other study ID # IVIG for encephalopathy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date December 1, 2024

Study information
Verified date October 2022
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Wu Fang, MD
Phone 8613883559467
Email 476679422@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Infection and inflammation is related to increased encephalopathy of prematurities.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Hours
Eligibility Inclusion Criteria: - preterm infants with encephalopathy Exclusion Criteria: - refuse the participate in the trial

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• human gamma globulin
human gamma globulin for preterm infants with encephalopathy of prematurities
• non-human gamma globulin
Non-human gamma globulin for preterm infants with encephalopathy of prematurities

Locations
Country Name City State
China Department of Pediatrics,Daping Hospital Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary structural changes of brain injury MRI/ultrasound will be used to assess the structural severities of brain injury. 100-days
Primary functional changes of brain injury Bayley score will be used to assess the functional severities of brain injury. 100-days
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