Neonatal EncephalopathyNCT02544100
Neonatal Neurologic Intensive Care Network of China
An observational study of Neonatal Encephalopathy and Suspected Neonatal Encephalopathy, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Encephalopathy, Suspected Neonatal Encephalopathy
- What is being tested?
- Database Entry/Biospecimen Collection
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal with severe encephalopathy or suspected severe encephalopathy.
Who may be able to join
- Postnatal age < or = 28 days
- Written informed consent of parent or guardian
- With one of the following items
- Hypoxic ischemic encephalopathy (HIE)
- Hydrocephalus
- Hypotonia
Show all 16Show fewer
- Interventricular hemorrhages
- Intracranial calcifications
- Intracranial hemorrhages
- Meningitis and other brain infections
- Metabolic diseases
- Microcephaly
- Neonatal stroke
- Spina bifid
- Cerebral arteriovenous malformations (AVMs)
- Congenital brain malformations
Who cannot join
- Known other major congenital anomalies but not not neurologic disease.
- Failed to get sample or the volume of collected biosamples is not enough.
- Parents refuse consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wenhao Zhou, Doctor contact
Guoqiang Cheng, Doctor contact
China1 site, 1 recruiting
- Recruiting
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Wenhao Zhou, Doctor, (+86)021-64931003, zwhchfu@126.com
About this study
The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. In addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.
Read the detailed description
The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information mainly including demographic, medical history, family condition, perinatal stage information, birth, growth \& feeding status, imaging, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. There are seven children's hospitals from 6 provinces in China to join in the collaboration network in first recruiting. In addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.
- Being tested
- Database Entry/Biospecimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Database Entry/Biospecimen CollectionOther
blood, urine, CFS samples and medical data collected
| Study group | Role | What they receive |
|---|---|---|
| Database Entry / Biospecimen Collection | Systematic Medical information of infants born with severe encephalopathy entered into database. In addition, Blood, urine, CFS samples will be collected. Receives: Other: Database Entry/Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Blood Samples
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
Measured: In 72 hours
Number of Urine Samples
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
Measured: In 72 hours
Secondary outcomes (4)
Number of Electronic Medical Records
To collect systemic medical information about neonatal encephalopathy.
Measured: To follow for the duration of hospital stay, an expected average of 4 weeks
Neurodevelopment(Bayley Scores)
To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSIDMI) and gain incidence of BSIMDI<70(Severe) or BSIMDI<85(Moderate).
Measured: At the age of 18 months
Neurological Evaluation(GMFM-88 Scores)
To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0~100 , Higher value means better gross motor function).
Measured: At the age of 18 months
Gene Mutation
To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using different genomic methods.
Measured: At the age of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Children's Hospital, Fujian of China, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangzhou Women and Children's Medical Center, Yuying Children's Hospital of Wenzhou Medical University, Maternal and Child Health Hospital of Hubei Province, The People's Hospital of Dehong Autonomous Prefecture, Guangzhou Medical University, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Wenhao Zhou, Doctor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544100
- Sponsor's protocol ID
- CHFudanU_NNICU5
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suarez JI, Geocadin R, Hall C, Le Roux PD, Smirnakis S, Wijman CA, Zaidat OO. The neurocritical care research network: NCRN. Neurocrit Care. 2012 Feb;16(1):29-34. doi: 10.1007/s12028-011-9612-x.
PubMed 21792751Narayanan JT, Murthy JM. New-onset acute symptomatic seizure in a neurological intensive care unit. Neurol India. 2007 Apr-Jun;55(2):136-40. doi: 10.4103/0028-3886.32784.
PubMed 17558117Hall CE, Mirski M, Palesch YY, Diringer MN, Qureshi AI, Robertson CS, Geocadin R, Wijman CA, Le Roux PD, Suarez JI; First Neurocritical Care Research Conference Investigators. Clinical trial design in the neurocritical care unit. Neurocrit Care. 2012 Feb;16(1):6-19. doi: 10.1007/s12028-011-9608-6.
PubMed 21792753Riviello JJ Jr. Pediatric neurocritical care. Introduction. Semin Pediatr Neurol. 2014 Dec;21(4):239-40. doi: 10.1016/j.spen.2014.12.009. Epub 2014 Dec 19. No abstract available.
PubMed 25727504Riviello JJ Jr, Chang C. The practice of pediatric neurocritical care by the child neurologist. Semin Pediatr Neurol. 2014 Dec;21(4):299-302. doi: 10.1016/j.spen.2014.12.007. Epub 2014 Dec 13.
PubMed 25727512Wainwright MS, Grimason M, Goldstein J, Smith CM, Amlie-Lefond C, Revivo G, Noah ZL, Harris ZL, Epstein LG. Building a pediatric neurocritical care program: a multidisciplinary approach to clinical practice and education from the intensive care unit to the outpatient clinic. Semin Pediatr Neurol. 2014 Dec;21(4):248-54. doi: 10.1016/j.spen.2014.10.006. Epub 2014 Nov 1.
PubMed 25727506Murphy SA, Bell MJ, Clark ME, Whalen MJ, Noviski N. Pediatric Neurocritical Care: A Short Survey of Current Perceptions and Practices. Neurocrit Care. 2015 Oct;23(2):149-58. doi: 10.1007/s12028-015-0120-2.
PubMed 25693892LaRovere KL, Graham RJ, Tasker RC; Pediatric Critical Nervous System Program (pCNSp). Pediatric neurocritical care: a neurology consultation model and implication for education and training. Pediatr Neurol. 2013 Mar;48(3):206-11. doi: 10.1016/j.pediatrneurol.2012.12.006.
PubMed 23419471Bonifacio SL, Glass HC, Peloquin S, Ferriero DM. A new neurological focus in neonatal intensive care. Nat Rev Neurol. 2011 Aug 2;7(9):485-94. doi: 10.1038/nrneurol.2011.119.
PubMed 21808297Liu L, Xu SH, Zhang P, Lu CM, Cheng GQ. [Effect of red blood cell transfusion on the oxygenation of mesenteric tissue in premature infants]. Zhonghua Er Ke Za Zhi. 2018 Sep 2;56(9):680-685. doi: 10.3760/cma.j.issn.0578-1310.2018.09.009. Chinese.
PubMed 30180407
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Neurologic Intensive Care Network of China
- ClinicalTrials.gov ID
- NCT02544100
- Acronym / sponsor ID
- CHFudanU_NNICU5
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Xiamen Children's Hospital, Fujian of China, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangzhou Women and Children's Medical Center, Yuying Children's Hospital of Wenzhou Medical University, Maternal and Child Health Hospital of Hubei Province, The People's Hospital of Dehong Autonomous Prefecture, Guangzhou Medical University, Nanfang Hospital, Southern Medical University
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Sep 2015 (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.
The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. In addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.
Detailed description
The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information mainly including demographic, medical history, family condition, perinatal stage information, birth, growth \& feeding status, imaging, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. There are seven children's hospitals from 6 provinces in China to join in the collaboration network in first recruiting. In addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Database Entry / Biospecimen Collection | – | Other: Database Entry/Biospecimen CollectionSystematic Medical information of infants born with severe encephalopathy entered into database. In addition, Blood, urine, CFS samples will be collected. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal with severe encephalopathy or suspected severe encephalopathy.
Key inclusion criteria (16 listed)
- Postnatal age < or = 28 days
- Written informed consent of parent or guardian
- With one of the following items
- Hypoxic ischemic encephalopathy (HIE)
- Hydrocephalus
Key exclusion criteria (3 listed)
- Known other major congenital anomalies but not not neurologic disease.
- Failed to get sample or the volume of collected biosamples is not enough.
- Parents refuse consent.
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 |
|---|---|---|
| Database Entry/Biospecimen Collectionblood, urine, CFS samples and medical data collected | Other | Database Entry / Biospecimen Collection |
Primary outcome
Number of Blood Samples
Time frame: In 72 hours
Blood samples-based data of genetic and biomarkers for the monitoring of neonatal encephalopathy.
Number of Urine Samples
Time frame: In 72 hours
Urine samples-based data of biomarkers for the monitoring of neonatal encephalopathy.
4 secondary outcomes
Number of Electronic Medical Records
Time frame: To follow for the duration of hospital stay, an expected average of 4 weeks
Neurodevelopment(Bayley Scores)
Time frame: At the age of 18 months
Neurological Evaluation(GMFM-88 Scores)
Time frame: At the age of 18 months
Gene Mutation
Time frame: At the age of 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 21792751Suarez JI, Geocadin R, Hall C, Le Roux PD, Smirnakis S, Wijman CA, Zaidat OO. The neurocritical care research network: NCRN. Neurocrit Care. 2012 Feb;16(1):29-34. doi: 10.1007/s12028-011-9612-x.
- Background: PubMed 17558117Narayanan JT, Murthy JM. New-onset acute symptomatic seizure in a neurological intensive care unit. Neurol India. 2007 Apr-Jun;55(2):136-40. doi: 10.4103/0028-3886.32784.
- Background: PubMed 21792753Hall CE, Mirski M, Palesch YY, Diringer MN, Qureshi AI, Robertson CS, Geocadin R, Wijman CA, Le Roux PD, Suarez JI; First Neurocritical Care Research Conference Investigators. Clinical trial design in the neurocritical care unit. Neurocrit Care. 2012 Feb;16(1):6-19. doi: 10.1007/s12028-011-9608-6.
- Background: PubMed 25727504Riviello JJ Jr. Pediatric neurocritical care. Introduction. Semin Pediatr Neurol. 2014 Dec;21(4):239-40. doi: 10.1016/j.spen.2014.12.009. Epub 2014 Dec 19. No abstract available.
- Background: PubMed 25727512Riviello JJ Jr, Chang C. The practice of pediatric neurocritical care by the child neurologist. Semin Pediatr Neurol. 2014 Dec;21(4):299-302. doi: 10.1016/j.spen.2014.12.007. Epub 2014 Dec 13.
- Background: PubMed 25727506Wainwright MS, Grimason M, Goldstein J, Smith CM, Amlie-Lefond C, Revivo G, Noah ZL, Harris ZL, Epstein LG. Building a pediatric neurocritical care program: a multidisciplinary approach to clinical practice and education from the intensive care unit to the outpatient clinic. Semin Pediatr Neurol. 2014 Dec;21(4):248-54. doi: 10.1016/j.spen.2014.10.006. Epub 2014 Nov 1.
- Background: PubMed 25693892Murphy SA, Bell MJ, Clark ME, Whalen MJ, Noviski N. Pediatric Neurocritical Care: A Short Survey of Current Perceptions and Practices. Neurocrit Care. 2015 Oct;23(2):149-58. doi: 10.1007/s12028-015-0120-2.
- Background: PubMed 23419471LaRovere KL, Graham RJ, Tasker RC; Pediatric Critical Nervous System Program (pCNSp). Pediatric neurocritical care: a neurology consultation model and implication for education and training. Pediatr Neurol. 2013 Mar;48(3):206-11. doi: 10.1016/j.pediatrneurol.2012.12.006.
- Background: PubMed 21808297Bonifacio SL, Glass HC, Peloquin S, Ferriero DM. A new neurological focus in neonatal intensive care. Nat Rev Neurol. 2011 Aug 2;7(9):485-94. doi: 10.1038/nrneurol.2011.119.
- Derived from this study: PubMed 30180407Liu L, Xu SH, Zhang P, Lu CM, Cheng GQ. [Effect of red blood cell transfusion on the oxygenation of mesenteric tissue in premature infants]. Zhonghua Er Ke Za Zhi. 2018 Sep 2;56(9):680-685. doi: 10.3760/cma.j.issn.0578-1310.2018.09.009. Chinese.
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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.
Wenhao Zhou, Doctor contact
Guoqiang Cheng, Doctor contact
Wenhao Zhou, Doctor study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy and Suspected Neonatal Encephalopathy, run by Children's Hospital of Fudan 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 16 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhao Zhou, Doctor (zwhchfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Blood Samples (time frame: In 72 hours). 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?
On the ClinicalTrials.gov record for NCT02544100, which also lists 10 linked publications.
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 5 Sep 2025.