NCT02822027

Brief Summary

Infection and inflammation is related to increased encephalopathy of prematurities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

8.5 years

First QC Date

June 24, 2016

Last Update Submit

October 13, 2022

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (2)

  • structural changes of brain injury

    MRI/ultrasound will be used to assess the structural severities of brain injury.

    100-days

  • functional changes of brain injury

    Bayley score will be used to assess the functional severities of brain injury.

    100-days

Study Arms (2)

human gamma globulin

EXPERIMENTAL

human gamma globulin for infants with encephalopathy of prematurities

Drug: human gamma globulinDrug: non-human gamma globulin

non-human gamma globulin

ACTIVE COMPARATOR

non-human gamma globulin for infants with encephalopathy of prematurities

Drug: human gamma globulinDrug: non-human gamma globulin

Interventions

human gamma globulinDRUG

human gamma globulin for preterm infants with encephalopathy of prematurities

human gamma globulinnon-human gamma globulin
non-human gamma globulinDRUG

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

human gamma globulinnon-human gamma globulin

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants with encephalopathy

You may not qualify if:

  • refuse the participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics,Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Central Study Contacts

Wu Fang, MD

CONTACT

8613883559467476679422@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 4, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

CN(1)