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NCT Number: NCT07733778

Neuroendoscopic 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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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

Treatment and study plan

Neuro-endoscopy

Procedure

Neuro-endoscopic lavage for management of neonatal intra-ventricular hemorrhage using normal saline

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Aboelmagd, Assistant lecturer

CONTACT

[email protected]

+20 01099474580

Mahmoud Gamal, Lecturer

CONTACT

[email protected]

+20 01000630887

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Neuro-endoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.