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Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02822027
Enrollment
20
Registered
2016-07-04
Start date
2016-06-01
Completion date
2024-12-01
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

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.

Interventions

DRUGhuman gamma globulin

human gamma globulin for preterm infants with encephalopathy of prematurities

DRUGnon-human gamma globulin

Non-human gamma globulin for preterm infants with encephalopathy of prematurities

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No

Inclusion criteria

* preterm infants with encephalopathy

Exclusion criteria

* refuse the participate in the trial

Design outcomes

Primary

MeasureTime frameDescription
structural changes of brain injury100-daysMRI/ultrasound will be used to assess the structural severities of brain injury.
functional changes of brain injury100-daysBayley score will be used to assess the functional severities of brain injury.

Countries

China

Contacts

Primary ContactWu Fang, MD
476679422@qq.com8613883559467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026