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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT02822027
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Description
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Brief Summary:
Infection and inflammation is related to increased encephalopathy of prematurities.

Condition or disease Intervention/treatment Phase
Preterm Infants Drug: human gamma globulin Drug: non-human gamma globulin Not Applicable

Detailed Description:
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. structural changes of brain injury [ Time Frame: 100-days ]
    MRI/ultrasound will be used to assess the structural severities of brain injury.

  2. functional changes of brain injury [ Time Frame: 100-days ]
    Bayley score will be used to assess the functional severities of brain injury.


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants with encephalopathy

Exclusion Criteria:

  • refuse the participate in the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822027


Contacts
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Contact: Wu Fang, MD 8613883559467 476679422@qq.com

Locations
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China, Chongqing
Department of Pediatrics,Daping Hospital Recruiting
Chongqing, Chongqing, China, 400042
Contact: Wu Fang, MD    8613883559467    476679422@qq.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
More Information
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Responsible Party: Fang Wu, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02822027    
Other Study ID Numbers: IVIG for encephalopathy
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Additional relevant MeSH terms:
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Brain Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Central Nervous System Diseases
 Nervous System Diseases
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs