TROPHY registry study design: a prospective, international multicenter study for the surgical treatment of posthemorrhagic hydrocephalus in neonates
Among children with hydrocephalus, neonates with intraventricular hemorrhage (IVH) and posthemorrhagic hydrocephalus (PH) are considered a group with one of the highest complication rates of treatment. Despite continued progress in neonatal care, a standardized and reliable guideline for surgical management is missing for this challenging condition. Thus, further research is warranted to compare common methods of surgical treatment. The introduction of neuroendoscopic lavage has precipitated the establishment of an international registry aimed at elaborating key elements of a standardized surgical treatment.
The registry is designed as a multicenter, international, prospective data collection for neonates aged 41 weeks gestation, with an indication for surgical treatment for IVH with ventricular dilatation and progressive hydrocephalus. The following initial temporizing surgical interventions, each used as standard treatment at participating centers, will be compared: external ventricular drainage (EVD), ventricular access device (VAD), ventricular subgaleal shunt (VSGS), and neuroendoscopic lavage (NEL). Type of surgery, perioperative data including complications and mortality, subsequent shunt surgeries, ventricular size, and neurological outcome will be recorded at 6, 12, 36, and 60 months.
An online, password-protected website will be used to collect the prospective data in a synchronized manner. As a prospective registry, data collection will be ongoing, with no prespecified endpoint. A prespecified analysis will take place after a total of 100 patients in the NEL group have been entered. Analyses will be performed for safety (6 months), shunt dependency (12, 24 months), and neurological outcome (60 months).
The design and online platform of the TROPHY registry will enable the collection of prospective data on different surgical procedures for investigation of safety, efficacy, and neurodevelopmental outcome of neonates with IVH and hydrocephalus. The long-term goal is to provide valid data on NEL that is prospective, international, and multicenter. With the comparison of different surgical treatment modalities, we hope to develop better therapy guidelines for this complex neurosurgical condition.
KeywordsCerebrospinal fluid drainage Neuroendoscopy Shunt Reservoir
Compliance with ethical standards
Conflict of interest
This registry received an initial financial support by B. Braun foundation. B. Braun does not hold any rights on the registry. No other conflict of interest according to the content of this paper is declared.
- 7.Sasidharan P, Marquez E, Dizon E, Sridhar CV (1986) Developmental outcome of infants with severe intracranial-intraventricular hemorrhage and hydrocephalus with and without ventriculoperitoneal shunt. Child’s nervous system: ChNS: official journal of the International Society for Pediatr Neurosurg 2(3):149–152CrossRefGoogle Scholar
- 11.Horinek D, Cihar M, Tichy M (2003) Current methods in the treatment of posthemorrhagic hydrocephalus in infants. Bratisl Lek Listy 104(11):347–351Google Scholar
- 13.Miranda P (2010) Intraventricular hemorrhage and posthemorrhagic hydrocephalus in the preterm infant. Minerva Pediatr 62(1):79–89Google Scholar
- 14.Wellons JC, Shannon CN, Kulkarni AV, Simon TD, Riva-Cambrin J, Whitehead WE, Oakes WJ, Drake JM, Luerssen TG, Walker ML, Kestle JR, Hydrocephalus Clinical Research Network (2009) A multicenter retrospective comparison of conversion from temporary to permanent cerebrospinal fluid diversion in very low birth weight infants with posthemorrhagic hydrocephalus. J Neurosurg Pediatr 4(1):50–55CrossRefGoogle Scholar
- 15.Mazzola CA, Choudhri AF, Auguste KI, Limbrick DD Jr, Rogido M, Mitchell L et al (2014) Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 2: management of posthemorrhagic hydrocephalus in premature infants. J Neurosurg Pediatr 14(Suppl 1):8–23CrossRefGoogle Scholar
- 16.Paraicz E (1979) Successful treatment of perinatal intraventricular haemorrhage. Acta Paediatr Acad Sci Hung 20(2–3):211–214Google Scholar
- 18.Siomin V, Cinalli G, Grotenhuis A, Golash A, Oi S, Kothbauer K, Weiner H, Roth J, Beni-Adani L, Pierre-Kahn A, Takahashi Y, Mallucci C, Abbott R, Wisoff J, Constantini S (2002) Endoscopic third ventriculostomy in patients with cerebrospinal fluid infection and/or hemorrhage. J Neurosurg 97(3):519–524CrossRefGoogle Scholar