Neuroendoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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 -

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 305471
• Ballabh P. Intraventricular hemorrhage in premature infants: mechanism of disease. Pediatr Res. 2010 Jan;67(1):1-8. doi: 10.1203/PDR.0b013e3181c1b176. PMID 19816235
• Levene 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. PMID 7259271
• Leijser 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. PMID 29367448
• Schulz 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. PMID 24702621
• Honeyman 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. PMID 41310238

Идентификаторы

NCT: NCT07733778 · Endoscopy in neonatal IVhge

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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