Skip to main content
SpringerLink
Log in

Randomized Clinical Trials in Pediatric Hydrocephalus

  • Chapter
  • First Online:
Book cover Cerebrospinal Fluid Disorders

  • 872 Accesses

Abstract

Among the options for research design for clinical investigators are case series (mostly retrospective), cohort studies (retrospective or prospective), case control studies, and randomized controlled trials. Analysis of data from prospective registries [1] using matching and/or propensity scores [2] has also gained popularity. Although nonexperimental design studies are frequently reported, randomized controlled trials have been considered the gold standard for the assessment of treatment efficacy, and the pros and cons have been extensively discussed in the literature [3, 4]. Randomized clinical trials of surgical procedures have some unique study design challenges and methods to address them. The most important attribute of randomized clinical trials, which is unique to that study design, is that randomization balances unknown confounders. Known confounders are also balanced, but this can be done with other research designs. Because it is not always possible to predict confounders in clinical research, randomization is the only method that has the ability to balance the unknown confounding factors.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 109.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Walicke P, Abosch A, Asher A, Barker FG, Ghogawala Z, Harbaugh R, et al. Launching effectiveness research to guide practice in neurosurgery: a National Institute Neurological Disorders and stroke workshop report. Neurosurgery. 2017;80:505–14.

    Article  Google Scholar 

  2. Wang S, Stone S, Weil AG, Fallah A, Warf BC, Ragheb J, et al. Comparative effectiveness of flexible versus rigid neuroendoscopy for endoscopic third ventriculostomy and choroid plexus cauterization: a propensity score-matched cohort and survival analysis. J Neurosurg Pediatr. 2017;19:585–91.

    Article  Google Scholar 

  3. Barker FG. Editorial: Randomized clinical trials and neurosurgery. J Neurosurg. 2016;124:552–6 discussion 556–557.

    Article  Google Scholar 

  4. Mansouri A, Cooper B, Shin SM, Kondziolka D. Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered? J Neurosurg. 2016;124:558–68.

    Article  Google Scholar 

  5. Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation. Ventriculomegaly Trial Group. Arch Dis Child. 1990;65:3–10.

    Google Scholar 

  6. Kennedy CR, Ayers S, Campbell MJ, Elbourne D, Hope P, Johnson A. Randomized, controlled trial of acetazolamide and furosemide in posthemorrhagic ventricular dilation in infancy: follow-up at 1 year. Pediatrics. 2001;108:597–607.

    Article  CAS  Google Scholar 

  7. Whitelaw A, Jary S, Kmita G, Wroblewska J, Musialik-Swietlinska E, Mandera M, et al. Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 years. Pediatrics. 2010;125:e852–8.

    Article  Google Scholar 

  8. de Vries LS, Groenendaal F, Liem KD, Heep A, Brouwer AJ, van’ t Verlaat E, et al. Treatment thresholds for intervention in posthaemorrhagic ventricular dilation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2018.

    Google Scholar 

  9. Drake JM, Kestle JR, Milner R, Cinalli G, Boop F, Piatt J Jr, et al. Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Neurosurgery. 1998;43:294–303 discussion 303–305.

    Article  CAS  Google Scholar 

  10. Pollack IF, Albright AL, Adelson PD. A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery. 1999;45:1399–408. discussion 1408–1411.

    Article  CAS  Google Scholar 

  11. Bierbrauer KS, Storrs BB, McLone DG, Tomita T, Dauser R. A prospective, randomized study of shunt function and infections as a function of shunt placement. Pediatr Neurosurg. 1990;16:287–91.

    Article  Google Scholar 

  12. Kestle JR, Drake JM, Cochrane DD, Milner R, Walker ML, Abbott R, et al. Lack of benefit of endoscopic ventriculoperitoneal shunt insertion: a multicenter randomized trial. J Neurosurg. 2003;98:284–90.

    Article  Google Scholar 

  13. Whitehead WE, Riva-Cambrin J, Kulkarni AV, Wellons JC, Rozzelle CJ, Tamber MS, et al. Ventricular catheter entry site and not catheter tip location predicts shunt survival: a secondary analysis of 3 large pediatric hydrocephalus studies. J Neurosurg Pediatr. 2017;19:157–67.

    Article  Google Scholar 

  14. Goyal P, Srivastava C, Ojha BK, Singh SK, Chandra A, Garg RK, et al. A randomized study of ventriculoperitoneal shunt versus endoscopic third ventriculostomy for the management of tubercular meningitis with hydrocephalus. Childs Nerv Syst. 2014;30:851–7.

    Article  Google Scholar 

  15. Kulkarni AV, Sgouros S, Constantini S. International infant hydrocephalus study: initial results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst. 2016;32:1039–48.

    Article  Google Scholar 

  16. Kulkarni AV, Schiff SJ, Mbabazi-Kabachelor E, Mugamba J, Ssenyonga P, Donnelly R, et al. Endoscopic treatment versus shunting for infant hydrocephalus in Uganda. N Engl J Med. 2017;377:2456–64.

    Article  Google Scholar 

  17. Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003;99:831–9.

    Article  Google Scholar 

  18. Rozzelle CJ, Leonardo J, Li V. Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatr. 2008;2:111–7.

    Article  Google Scholar 

  19. Whitelaw A, Evans D, Carter M, Thoresen M, Wroblewska J, Mandera M, et al. Randomized clinical trial of prevention of hydrocephalus after intraventricular hemorrhage in preterm infants: brain-washing versus tapping fluid. Pediatrics. 2007;119:e1071–8.

    Article  Google Scholar 

  20. Luyt K, Jary S, Lea C, Young G, Odd D, Miller H, et al. Drainage irrigation and fibrinolytic therapy (DRIFT) for post haemorrhagic ventricular dilatation: improved cognitive ability at school-age. Presented at Pediatric Academic Societies Meeting, San Francisco; 2017.

    Google Scholar 

  21. Etus V, Kahilogullari G, Karabagli H, Unlu A. Early endoscopic ventricular irrigation for the treatment of neonatal Posthemorrhagic hydrocephalus: a feasible treatment option or not? a multicenter study. Turk Neurosurg. 2018;28:137–41.

    PubMed  Google Scholar 

  22. 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;13:626–35.

    Article  Google Scholar 

  23. Kestle J, Drake J, Milner R, Sainte-Rose C, Cinalli G, Boop F, et al. Long-term follow-up data from the shunt design trial. Pediatr Neurosurg. 2000;33:230–6.

    Article  CAS  Google Scholar 

  24. Taha J, Crone K. Endoscopically guided shunt placement. Techn Neurosurg. 1996;1:159–67.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. University of Utah, Department of Neurological Surgery, Salt Lake City, UT, USA

    Evan J. Joyce

  2. Alberta Children’s Hospital, Department of Clinical Neurosciences, Calgary, AB, Canada

    Jay Riva-Cambrin

  3. Primary Children’s Hospital, University of Utah, Department of Neurosurgery, Salt Lake City, UT, USA

    John R. W. Kestle

Authors
  1. Evan J. Joyce
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jay Riva-Cambrin
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. John R. W. Kestle
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to John R. W. Kestle .

Editor information

Editors and Affiliations

  1. Department of Neurological Surgery, Washington University School of Medicine, St. Louis Children’s Hospital, St. Louis, MO, USA

    David D. Limbrick Jr.

  2. Nationwide Children’s Hospital, Department of Neurosurgery, The Ohio State University College of Medicine, Columbus, OH, USA

    Jeffrey R. Leonard

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Joyce, E.J., Riva-Cambrin, J., Kestle, J.R.W. (2019). Randomized Clinical Trials in Pediatric Hydrocephalus. In: Limbrick Jr., D., Leonard, J. (eds) Cerebrospinal Fluid Disorders . Springer, Cham. https://doi.org/10.1007/978-3-319-97928-1_19

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-97928-1_19

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-97927-4

  • Online ISBN: 978-3-319-97928-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation