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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Not Applicable
Recruiting
Conditions
Preterm Infants
Interventions
Drug: human gamma globulin
Drug: non-human gamma globulin
Registration Number
NCT02822027
Lead Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  • preterm infants with encephalopathy
Exclusion Criteria
  • refuse the participate in the trial

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
human gamma globulinhuman gamma globulinhuman gamma globulin for infants with encephalopathy of prematurities
human gamma globulinnon-human gamma globulinhuman gamma globulin for infants with encephalopathy of prematurities
non-human gamma globulinhuman gamma globulinnon-human gamma globulin for infants with encephalopathy of prematurities
non-human gamma globulinnon-human gamma globulinnon-human gamma globulin for infants with encephalopathy of prematurities
Primary Outcome Measures
NameTimeMethod
structural changes of brain injury100-days

MRI/ultrasound will be used to assess the structural severities of brain injury.

functional changes of brain injury100-days

Bayley score will be used to assess the functional severities of brain injury.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Pediatrics,Daping Hospital

🇨🇳

Chongqing, Chongqing, China

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