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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 24, 2016
First Posted Date  ICMJE July 4, 2016
Last Update Posted Date October 14, 2022
Actual Study Start Date  ICMJE June 1, 2016
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • structural changes of brain injury [ Time Frame: 100-days ]
    MRI/ultrasound will be used to assess the structural severities of brain injury.
  • functional changes of brain injury [ Time Frame: 100-days ]
    Bayley score will be used to assess the functional severities of brain injury.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Official Title  ICMJE Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Preterm Infants
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: human gamma globulin
    human gamma globulin for infants with encephalopathy of prematurities
    Interventions:
    • Drug: human gamma globulin
    • Drug: non-human gamma globulin
  • Active Comparator: non-human gamma globulin
    non-human gamma globulin for infants with encephalopathy of prematurities
    Interventions:
    • Drug: human gamma globulin
    • Drug: non-human gamma globulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2016)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • preterm infants with encephalopathy

Exclusion Criteria:

  • refuse the participate in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wu Fang, MD 8613883559467 476679422@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02822027
Other Study ID Numbers  ICMJE IVIG for encephalopathy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP