Skip to main content
OpenTrials
Completed

NCT Number: NCT01480349

Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-Hemorrhagic Hydrocephalus

Age range

Up to 180 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Sick Children's Hospital, Toronto, Ontario, Canada

Loading trial locations.

About this study

Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal. These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known. The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES. Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures. In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • premature neonates with birth weights less than 1500 grams
  • Grade III or IV intraventricular hemorrhage
  • Fronto-occipital horn ratio greater than or equal to 0.50

Exclusion criteria

  • Less than 72 hour life expectancy from other medical problems

Treatment and study plan

Primary outcomes

  1. Specific Aim I: Proportion of temporization

    Time frame: 5 years

    The proportion of all infants entering the study who meet the criteria for surgical temporization.

  2. Specific Aim 2: Conversion proportion

    Time frame: 5 years

    The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.

  3. Specific Aim 3: Surgery Checklist Scores

    Time frame: 5 years

    Surgery checklist scores of individual surgeon performance in standardized procedures.

Secondary outcomes

  1. Protocol adherence

    Time frame: 5 years

    Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.

  2. CSF Infection

    Time frame: 5 years

    Incidence of CSF infection while on the protocol.

  3. Neurodevelopmental Outcomes

    Time frame: 7 years

    Subscores from the Bayley Scales of Infant Development, version III (BSID-III) to include cognitive, language and motor subtests will be obtained for patients undergoing BSID-III testing at 18-22 and 36-42 months of age.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study

Acronym: SOPHH

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 28, 2011
Registry last updated
Dec 26, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.