Neonatal Intra-ventricular HemorrhageNCT07733778
Neuroendoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage
A study testing Neuro-endoscopy in people with Neonatal Intra-ventricular Hemorrhage, run by Assiut University.
Trial summary
Neonatal intraventricular hemorrhage (IVH) is a major cause of morbidity and mortality in premature infants and is frequently associated with post-hemorrhagic ventricular dilatation (PHVD) and hydrocephalus. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Intra-ventricular Hemorrhage
- What is being tested?
- Neuro-endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2029
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates aged 28 days or less at the time of presentation.
- Neonates diagnosed with severe IVH with ventricular dilatation (Grade III or IV on Papile classification).
- Written informed consent obtained from parents or legal guardians -
Who cannot join
- Grade I or Grade II intra-ventricular hemorrhage according to the Papile classification.
- Major congenital brain malformations, like Dandy-Walker malformation and Holoprosencephaly or severe congenital anomalies incompatible with life.
- Neonates with active central nervous system infection (meningitis or ventriculitis).
- Severe coagulopathy not correctable before surgery.
- Refusal of parental or legal guardian consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Neuro-endoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage
Neonatal intraventricular hemorrhage (IVH) is a major cause of morbidity and mortality in premature infants and is frequently associated with post-hemorrhagic ventricular dilatation (PHVD) and hydrocephalus. Neuroendoscopic lavage (NEL) is a minimally invasive technique that allows removal of intraventricular blood clots and inflammatory debris, potentially reducing cerebrospinal fluid pathway obstruction and the need for permanent cerebrospinal fluid diversion. This prospective interventional study aims to evaluate the safety, feasibility, and clinical outcomes of neuroendoscopic lavage in neonates with IVH-related hydrocephalus. Patients will be assessed clinically and radiologically before and after the procedure, with follow-up focusing on ventricular size, shunt dependency, procedure-related complications, and neurological outcomes.
Read the detailed description
Neonatal intra-ventricular hemorrhage (IVH) is one of the most common and serious neurological complications affecting premature infants, particularly those born before 32 weeks of gestation and those with very low birth weight. Despite advances in neonatal intensive care, IVH remains a significant cause of mortality and long-term neurodevelopmental disability worldwide (1,2).
The pathogenesis of IVH is closely related to the fragility of the germinal matrix vasculature and the immaturity of cerebral auto-regulation in premature neonates. Fluctuations in cerebral blood flow may result in rupture of these fragile vessels, leading to hemorrhage that can extend into the ventricular system (2,3).
The severity of IVH is commonly classified according to the Papile grading system into four grades. Grades III and IV are associated with the highest rates of morbidity and mortality and carry a significant risk of developing post-hemorrhagic ventricular dilatation (PHVD) and post-hemorrhagic hydrocephalus (PHH) (1,4).
Post-hemorrhagic ventricular dilatation develops as a result of obstruction of cerebrospinal fluid (CSF) pathways by intra-ventricular blood clots and inflammatory debris. Furthermore, blood degradation products trigger inflammatory reactions that impair CSF circulation and absorption, leading to progressive ventricular enlargement and secondary brain injury (3,5).
Several treatment modalities have been proposed for the management of PHVD and PHH, including serial lumbar punctures, ventricular reservoir insertion, ventriculo-subgaleal shunting, external ventricular drainage (EVD), and ventriculo-peritoneal (VP) shunt placement. However, these methods primarily provide CSF diversion without directly removing intra-ventricular blood products that contribute to ongoing inflammation and ventricular dilatation (5,6).
Neuro-endoscopic lavage (NEL) has recently emerged as a promising minimally invasive technique for the treatment of severe neonatal IVH. The procedure involves endoscopic irrigation of the ventricular system with the aim of removing blood clots and inflammatory debris, restoring CSF pathways, and reducing ventricular enlargement. By addressing the underlying pathological substrate rather than merely diverting CSF, NEL may reduce shunt dependency and improve neurological outcomes (6,7).
Recent studies have reported encouraging results regarding the safety and efficacy of neuro-endoscopic lavage in neonates with severe IVH. These studies demonstrated reduction in ventricular size, lower rates of permanent VP shunt insertion, and favorable neurodevelopmental outcomes compared with conventional treatment methods (6,7). Nevertheless, current evidence remains limited, and further prospective studies are required to establish the exact role of neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage.
Therefore, this study aims to evaluate the role of neuro-endoscopic lavage in neonates with intra-ventricular hemorrhage and to assess its impact on ventricular dilatation, shunt dependency, complications, and clinical outcomes.
- Conditions
- Neonatal Intra-ventricular Hemorrhage
- Being tested
- Neuro-endoscopy
- Keywords
- Neuro-endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-endoscopyProcedure or surgery
Neuro-endoscopic lavage for management of neonatal intra-ventricular hemorrhage using normal saline
| Study group | Role | What they receive |
|---|---|---|
| Neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage | Other | Single arm Receives: Procedure: Neuro-endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage
To evaluate the rate of post hemorrhagic ventricular dilatation and the need for permanent VP shunt after neuroendoscopic lavage for neonatal intra-ventricular hemorrhage
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intra-ventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Aboelmagd Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733778
- Sponsor's protocol ID
- Endoscopy in neonatal IVhge
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.
PubMed 305471Ballabh P. Intraventricular hemorrhage in premature infants: mechanism of disease. Pediatr Res. 2010 Jan;67(1):1-8. doi: 10.1203/PDR.0b013e3181c1b176.
PubMed 19816235Levene MI, Wigglesworth JS, Dubowitz V. Cerebral structure and intraventricular haemorrhage in the neonate: a real-time ultrasound study. Arch Dis Child. 1981 Jun;56(6):416-24. doi: 10.1136/adc.56.6.416.
PubMed 7259271Leijser LM, Miller SP, van Wezel-Meijler G, Brouwer AJ, Traubici J, van Haastert IC, Whyte HE, Groenendaal F, Kulkarni AV, Han KS, Woerdeman PA, Church PT, Kelly EN, van Straaten HLM, Ly LG, de Vries LS. Posthemorrhagic ventricular dilatation in preterm infants: When best to intervene? Neurology. 2018 Feb 20;90(8):e698-e706. doi: 10.1212/WNL.0000000000004984. Epub 2018 Jan 24.
PubMed 29367448Schulz M, Buhrer C, Pohl-Schickinger A, Haberl H, Thomale UW. Neuroendoscopic lavage for the treatment of intraventricular hemorrhage and hydrocephalus in neonates. J Neurosurg Pediatr. 2014 Jun;13(6):626-35. doi: 10.3171/2014.2.PEDS13397. Epub 2014 Apr 4.
PubMed 24702621Honeyman SI, Martin SC, Lawrence T, Calisto A, Jayamohan J, Magdum S. Neuroendoscopic lavage for the management of neonatal post-haemorrhagic hydrocephalus: A systematic review and meta-analysis. Childs Nerv Syst. 2025 Nov 28;41(1):385. doi: 10.1007/s00381-025-07023-9.
PubMed 41310238
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neuro-endoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT07733778
- Acronym / sponsor ID
- Endoscopy in neonatal IVhge
- Conditions
- Neonatal Intra-ventricular Hemorrhage
- Keywords
- Neuro-endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 29 Jul 2026 (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.
Neonatal intraventricular hemorrhage (IVH) is a major cause of morbidity and mortality in premature infants and is frequently associated with post-hemorrhagic ventricular dilatation (PHVD) and hydrocephalus. Neuroendoscopic lavage (NEL) is a minimally invasive technique that allows removal of intraventricular blood clots and inflammatory debris, potentially reducing cerebrospinal fluid pathway obstruction and the need for permanent cerebrospinal fluid diversion. This prospective interventional study aims to evaluate the safety, feasibility, and clinical outcomes of neuroendoscopic lavage in neonates with IVH-related hydrocephalus. Patients will be assessed clinically and radiologically before and after the procedure, with follow-up focusing on ventricular size, shunt dependency, procedure-related complications, and neurological outcomes.
Detailed description
Neonatal intra-ventricular hemorrhage (IVH) is one of the most common and serious neurological complications affecting premature infants, particularly those born before 32 weeks of gestation and those with very low birth weight. Despite advances in neonatal intensive care, IVH remains a significant cause of mortality and long-term neurodevelopmental disability worldwide (1,2).
The pathogenesis of IVH is closely related to the fragility of the germinal matrix vasculature and the immaturity of cerebral auto-regulation in premature neonates. Fluctuations in cerebral blood flow may result in rupture of these fragile vessels, leading to hemorrhage that can extend into the ventricular system (2,3).
The severity of IVH is commonly classified according to the Papile grading system into four grades. Grades III and IV are associated with the highest rates of morbidity and mortality and carry a significant risk of developing post-hemorrhagic ventricular dilatation (PHVD) and post-hemorrhagic hydrocephalus (PHH) (1,4).
Post-hemorrhagic ventricular dilatation develops as a result of obstruction of cerebrospinal fluid (CSF) pathways by intra-ventricular blood clots and inflammatory debris. Furthermore, blood degradation products trigger inflammatory reactions that impair CSF circulation and absorption, leading to progressive ventricular enlargement and secondary brain injury (3,5).
Several treatment modalities have been proposed for the management of PHVD and PHH, including serial lumbar punctures, ventricular reservoir insertion, ventriculo-subgaleal shunting, external ventricular drainage (EVD), and ventriculo-peritoneal (VP) shunt placement. However, these methods primarily provide CSF diversion without directly removing intra-ventricular blood products that contribute to ongoing inflammation and ventricular dilatation (5,6).
Neuro-endoscopic lavage (NEL) has recently emerged as a promising minimally invasive technique for the treatment of severe neonatal IVH. The procedure involves endoscopic irrigation of the ventricular system with the aim of removing blood clots and inflammatory debris, restoring CSF pathways, and reducing ventricular enlargement. By addressing the underlying pathological substrate rather than merely diverting CSF, NEL may reduce shunt dependency and improve neurological outcomes (6,7).
Recent studies have reported encouraging results regarding the safety and efficacy of neuro-endoscopic lavage in neonates with severe IVH. These studies demonstrated reduction in ventricular size, lower rates of permanent VP shunt insertion, and favorable neurodevelopmental outcomes compared with conventional treatment methods (6,7). Nevertheless, current evidence remains limited, and further prospective studies are required to establish the exact role of neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage.
Therefore, this study aims to evaluate the role of neuro-endoscopic lavage in neonates with intra-ventricular hemorrhage and to assess its impact on ventricular dilatation, shunt dependency, complications, and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage | Other | Procedure: Neuro-endoscopySingle arm |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates aged 28 days or less at the time of presentation.
- Neonates diagnosed with severe IVH with ventricular dilatation (Grade III or IV on Papile classification).
- Written informed consent obtained from parents or legal guardians -
Key exclusion criteria (5 listed)
- Grade I or Grade II intra-ventricular hemorrhage according to the Papile classification.
- Major congenital brain malformations, like Dandy-Walker malformation and Holoprosencephaly or severe congenital anomalies incompatible with life.
- Neonates with active central nervous system infection (meningitis or ventriculitis).
- Severe coagulopathy not correctable before surgery.
- Refusal of parental or legal guardian 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 |
|---|---|---|
| Neuro-endoscopyNeuro-endoscopic lavage for management of neonatal intra-ventricular hemorrhage using normal saline | Procedure or surgery | Neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage |
Primary outcome
Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage
Time frame: 3 years
To evaluate the rate of post hemorrhagic ventricular dilatation and the need for permanent VP shunt after neuroendoscopic lavage for neonatal intra-ventricular hemorrhage
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 31 Jul 2026.
- Background: PubMed 305471Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34. doi: 10.1016/s0022-3476(78)80282-0.
- Background: PubMed 19816235Ballabh P. Intraventricular hemorrhage in premature infants: mechanism of disease. Pediatr Res. 2010 Jan;67(1):1-8. doi: 10.1203/PDR.0b013e3181c1b176.
- Background: PubMed 7259271Levene MI, Wigglesworth JS, Dubowitz V. Cerebral structure and intraventricular haemorrhage in the neonate: a real-time ultrasound study. Arch Dis Child. 1981 Jun;56(6):416-24. doi: 10.1136/adc.56.6.416.
- Background: PubMed 29367448Leijser LM, Miller SP, van Wezel-Meijler G, Brouwer AJ, Traubici J, van Haastert IC, Whyte HE, Groenendaal F, Kulkarni AV, Han KS, Woerdeman PA, Church PT, Kelly EN, van Straaten HLM, Ly LG, de Vries LS. Posthemorrhagic ventricular dilatation in preterm infants: When best to intervene? Neurology. 2018 Feb 20;90(8):e698-e706. doi: 10.1212/WNL.0000000000004984. Epub 2018 Jan 24.
- Background: PubMed 24702621Schulz M, Buhrer C, Pohl-Schickinger A, Haberl H, Thomale UW. Neuroendoscopic lavage for the treatment of intraventricular hemorrhage and hydrocephalus in neonates. J Neurosurg Pediatr. 2014 Jun;13(6):626-35. doi: 10.3171/2014.2.PEDS13397. Epub 2014 Apr 4.
- Background: PubMed 41310238Honeyman SI, Martin SC, Lawrence T, Calisto A, Jayamohan J, Magdum S. Neuroendoscopic lavage for the management of neonatal post-haemorrhagic hydrocephalus: A systematic review and meta-analysis. Childs Nerv Syst. 2025 Nov 28;41(1):385. doi: 10.1007/s00381-025-07023-9.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-endoscopy in people with Neonatal Intra-ventricular Hemorrhage, run by Assiut 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 5 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 31 Jul 2026. 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?
Contact Ahmed Aboelmagd, Assistant lecturer (+20 01099474580, ahmedaboelmagd@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage (time frame: 3 years). 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 NCT07733778, which also lists 6 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 31 Jul 2026.