Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02822027
Collaborator
(none)
20
1
2
78
0.3
Study Details
Study Description
Brief Summary
Infection and inflammation is related to increased encephalopathy of prematurities.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.
Study Design
Study Type:
Interventional
Anticipated 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
:
Jun 1, 2016
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| 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
Primary Outcome Measures
- structural changes of brain injury [100-days]
MRI/ultrasound will be used to assess the structural severities of brain injury.
- functional changes of brain injury [100-days]
Bayley score will be used to assess the functional severities of brain injury.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 6 Hours
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- preterm infants with encephalopathy
Exclusion Criteria:
- refuse the participate in the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pediatrics,Daping Hospital | Chongqing | Chongqing | China | 400042 |
Sponsors and Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.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:
Jul 4, 2016
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms: