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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT02822027
Recruitment Status : Unknown
Verified June 2016 by Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : July 4, 2016
Last Update Posted : July 4, 2016
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 July 4, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date July 2018   (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 No Changes Posted
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2018   (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 information is only displayed when the study is recruiting subjects
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
Responsible Party Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Sponsor  ICMJE Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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 June 2016

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