Intraventricular Hemorrhage of PrematurityROPEDACEOIHIPINCT07157020
Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
A study testing ommaya capsule implantation technique in people with Intraventricular Hemorrhage of Prematurity, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention. 2. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity
- What is being tested?
- ommaya capsule implantation technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age: 23+0 weeks to 36+6 weeks;
- Post-hemorrhagic hydrocephalus is confirmed by cranial ultrasound or other cranial imaging examinations.
- No cerebrospinal fluid drainage treatment was received before enrollment.
Who cannot join
- Excluding secondary IVH, including but not limited to congenital malformations, vitamin K1 deficiency, abnormal coagulation function, etc.
- Excluding hydrocephalus caused by other reasons, including but not limited to infection, congenital malformations, intracranial space-occupying lesions, etc.
- Treatment before diagnosis of hydrocephalus after intraventricular hemorrhage or suspected presence of central nervous system infection.
About this study
Official title: A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
- Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention.
- Apply ultrasound radiomics technology to explore and formulate new standards for imaging diagnosis and treatment; By integrating metabolomics, ultrasound radiomics and clinical data, high-risk individuals for intracranial hemorrhage and their relationship with prognosis can be identified early.
- To explore whether advancing the indication for surgical intervention of hydrocephalus in preterm infants after hemorrhage from ventricular index P97+4mm to P97 and whether repeated lumbar puncture and drainage can improve their prognosis, with the aim of clarifying the optimal timing for intervention of hydrocephalus in preterm infants after hemorrhage and optimizing the treatment methods.
- Being tested
- ommaya capsule implantation technique
- Keywords
- Intraventricular Hemorrhage of Prematurity, prevention, early detection, clinical evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ommaya capsule implantation techniqueProcedure or surgery
Also called Lumbar puncture drainage
Intervention criteria: Low-threshold intervention group and high--threshold intervention group
| Study group | Role | What they receive |
|---|---|---|
| Low-threshold intervention group | Experimental | VI>P97，but ≤ P97+4mm Receives: Procedure: ommaya capsule implantation technique |
| high-threshold intervention group | Experimental | VI>P97+4mm Receives: Procedure: ommaya capsule implantation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.
NDI can be diagnosed if any of the following conditions are met.
- Cerebral palsy;
- Griffiths score <85 points for the corresponding age: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively. Any assessment score lower than 85 points is considered a positive event.
- Sensorineural or mixed hearing impairment and non-congenital hearing loss require hearing AIDS or cochlear implants ④ Bilateral visual impairment;
- Epilepsy.
Measured: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157020
- Sponsor's protocol ID
- SAHoWMU-CR2025-06-108
- Acronym
- ROPEDACEOIHIPI
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Multi-center and Multidisciplinary Research Project on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
- ClinicalTrials.gov ID
- NCT07157020
- Acronym / sponsor ID
- ROPEDACEOIHIPI / SAHoWMU-CR2025-06-108
- Keywords
- Intraventricular Hemorrhage of Prematurity, prevention, early detection, clinical evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- 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.
- Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a scientific basis for optimizing clinical intervention.
- Apply ultrasound radiomics technology to explore and formulate new standards for imaging diagnosis and treatment; By integrating metabolomics, ultrasound radiomics and clinical data, high-risk individuals for intracranial hemorrhage and their relationship with prognosis can be identified early.
- To explore whether advancing the indication for surgical intervention of hydrocephalus in preterm infants after hemorrhage from ventricular index P97+4mm to P97 and whether repeated lumbar puncture and drainage can improve their prognosis, with the aim of clarifying the optimal timing for intervention of hydrocephalus in preterm infants after hemorrhage and optimizing the treatment methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-threshold intervention group | Experimental | Procedure: ommaya capsule implantation techniqueVI>P97，but ≤ P97+4mm |
| high-threshold intervention group | Experimental | Procedure: ommaya capsule implantation techniqueVI>P97+4mm |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age: 23+0 weeks to 36+6 weeks;
- Post-hemorrhagic hydrocephalus is confirmed by cranial ultrasound or other cranial imaging examinations.
- No cerebrospinal fluid drainage treatment was received before enrollment.
Key exclusion criteria (3 listed)
- Excluding secondary IVH, including but not limited to congenital malformations, vitamin K1 deficiency, abnormal coagulation function, etc.
- Excluding hydrocephalus caused by other reasons, including but not limited to infection, congenital malformations, intracranial space-occupying lesions, etc.
- Treatment before diagnosis of hydrocephalus after intraventricular hemorrhage or suspected presence of central nervous system infection.
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 |
|---|---|---|
| ommaya capsule implantation techniqueAlso: Lumbar puncture drainageIntervention criteria: Low-threshold intervention group and high--threshold intervention group | Procedure or surgery | Low-threshold intervention group, high-threshold intervention group |
Primary outcome
Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years.
Time frame: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively.
NDI can be diagnosed if any of the following conditions are met. * Cerebral palsy; * Griffiths score <85 points for the corresponding age: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively. Any assessment score lower than 85 points is considered a positive event. * Sensorineural or mixed hearing impairment and non-congenital hearing loss require hearing AIDS or cochlear implants ④ Bilateral visual impairment; * Epilepsy.
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ommaya capsule implantation technique in people with Intraventricular Hemorrhage of Prematurity, run by Second Affiliated Hospital of Wenzhou Medical University.
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 3 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: opening soon, 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or the occurrence of neurodevelopmental disorders (NDI) before the corrected gestational age of 2 years. (time frame: The assessment times are CA at 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months respectively.). 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 5 Sep 2025.