Preterm InfantsNCT02822027
Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
A study testing human gamma globulin and non-human gamma globulin in people with Preterm Infants, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Infection and inflammation is related to increased encephalopathy of prematurities. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Preterm Infants
- What is being tested?
- human gamma globulin and non-human gamma globulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants with encephalopathy
Who cannot join
- refuse the participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics,Daping Hospital
Chongqing, Chongqing Municipality, 400042
Wu Fang, MD, 8613883559467, 476679422@qq.com
About this study
Infection and inflammation is related to increased encephalopathy of prematurities.
Read the detailed description
Animal studies have verified intravenous immunoglobin can reduce brain injury. However, no studies in preterm infants were reported.
- Conditions
- Preterm Infants
- Being tested
- human gamma globulin, non-human gamma globulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human gamma globulinDrug
human gamma globulin for preterm infants with encephalopathy of prematurities
non-human gamma globulinDrug
Non-human gamma globulin for preterm infants with encephalopathy of prematurities
| Study group | Role | What they receive |
|---|---|---|
| human gamma globulin | Experimental | human gamma globulin for infants with encephalopathy of prematurities Receives: Drug: human gamma globulin; Drug: non-human gamma globulin |
| non-human gamma globulin | Active comparator | non-human gamma globulin for infants with encephalopathy of prematurities Receives: Drug: human gamma globulin; Drug: non-human gamma globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
structural changes of brain injury
MRI/ultrasound will be used to assess the structural severities of brain injury.
Measured: 100-days
functional changes of brain injury
Bayley score will be used to assess the functional severities of brain injury.
Measured: 100-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Wu, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822027
- Sponsor's protocol ID
- IVIG for encephalopathy
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2016
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity
- ClinicalTrials.gov ID
- NCT02822027
- Acronym / sponsor ID
- IVIG for encephalopathy
- Conditions
- Preterm Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human gamma globulin | Experimental | Drug: human gamma globulin, Drug: non-human gamma globulinhuman gamma globulin for infants with encephalopathy of prematurities |
| non-human gamma globulin | Active comparator | Drug: human gamma globulin, Drug: non-human gamma globulinnon-human gamma globulin for infants with encephalopathy of prematurities |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants with encephalopathy
Key exclusion criteria (1 listed)
- refuse the participate in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human gamma globulinhuman gamma globulin for preterm infants with encephalopathy of prematurities | Drug | human gamma globulin, non-human gamma globulin |
| non-human gamma globulinNon-human gamma globulin for preterm infants with encephalopathy of prematurities | Drug | human gamma globulin, non-human gamma globulin |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human gamma globulin and non-human gamma globulin in people with Preterm Infants, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Fang, MD (8613883559467, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
structural changes of brain injury (time frame: 100-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.