Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years - 22/10/20

Doi : 10.1016/j.jpeds.2020.08.014

Mehmet N. Cizmeci, MD ^1,^2,³, Floris Groenendaal, MD, PhD ^1,², Kian D. Liem, MD, PhD ⁴, Ingrid C. van Haastert, MA, PhD ^1,², Isabel Benavente-Fernández, MD, PhD ⁵, Henrica L.M. van Straaten, MD, PhD ⁶, Sylke Steggerda, MD, PhD ⁷, Bert J. Smit, MD, PhD ⁸, Andrew Whitelaw, MD, FRCPCH ⁹, Peter Woerdeman, MD, PhD ¹⁰, Axel Heep, MD ^9,^{^{∗
Contributed equally.}}, Linda S. de Vries, MD, PhD ^1,^2,^⁎
and the
ELVIS study group^{^†}
List of members of the ELVIS study group is available at www.jpeds.com (Appendix).
Kuo S. Han, MD, PhD ¹¹, Hendrik J. ter Horst, MD ¹², Koen P. Dijkman, MD ¹³, David Ley, MD ¹⁴, Vineta Fellman, MD ¹⁴, Timo R. de Haan, MD ¹⁵, Annemieke J. Brouwer, MD ^16,¹⁷, Manon J.N.L. Benders, MD, PhD ^18,¹⁹, Jeroen Dudink, MD, MSc, PhD ^18,¹⁹, Ellen van’t Verlaat, MD ²⁰, Paul Govaert, MD ²⁰, Renate M.C. Swarte, MD ²⁰, Monique Rijken, MD ²¹, Gerda van Wezel-Meijler, MD, PhD ²², Thais Agut Quijano, MD ²³, Uli Barcik, MD ²³, Amit M. Mathur, MD ²⁴, Andre M. Graca, MD, PhD ²⁵
¹¹ Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands
¹² Department of Neonatology, University Medical Center Groningen, Groningen, The Netherlands
¹³ Department of Neonatology, Máxima Medical Center, Veldhoven, The Netherlands
¹⁴ Department of Pediatrics, Institute of Clinical Sciences, Lund, Sweden
¹⁵ Department of Neonatology, Emma Children's Hospital, Academic Medical Center, University of Amsterdam, The Netherlands
¹⁶ Department of Neonatology, University Medical Center Utrecht, Utrecht, The Netherlands
¹⁷ University of Applied Sciences, Utrecht, The Netherlands
¹⁸ Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands
¹⁹ University Medical Center Utrecht, Utrecht Brain Center, The Netherlands
²⁰ Department of Neonatology, Erasmus Medical Center, Rotterdam, The Netherlands
²¹ Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands
²² Department of Neonatology, Isala Women and Children's Hospital, Zwolle, The Netherlands
²³ Department of Neonatology, Hospital Sant Joan de Deu, Barcelona, Spain
²⁴ Division of Newborn Medicine, Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine, St Louis, MO, USA
²⁵ Department of Neonatology, Hospital de Santa Maria, Lisbon, Portugal

¹ Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht
² University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands
³ Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada
⁴ Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, the Netherlands
⁵ Department of Neonatology, ‘Puerta del Mar’ University Hospital, Cadiz, Spain
⁶ Department of Neonatology, Isala Women and Children's Hospital, Zwolle, the Netherlands
⁷ Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands
⁸ Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, the Netherlands
⁹ Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom
¹⁰ Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, the Netherlands

^∗Reprint requests: Linda S. de Vries, MD, PhD, Emeritus Professor of Neonatal Neurology, Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht & UMC Utrecht Brain Center, KE 04.123.1 Lundlaan 6, 3584 EA Utrecht, the NetherlandsEmeritus Professor of Neonatal NeurologyDepartment of NeonatologyWilhelmina Children's HospitalUniversity Medical Center Utrecht & UMC Utrecht Brain CenterKE 04.123.1 Lundlaan 6Utrecht3584 EAthe Netherlands

Abstract

Objective

To compare the effect of intervention at low vs high threshold of ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability.

Study design

This multicenter randomized controlled trial reviewed lumbar punctures initiated after either a low threshold (ventricular index of >p97 and anterior horn width of >6 mm) or high threshold (ventricular index of >p97 + 4 mm and anterior horn width of >10 mm). The composite adverse outcome was defined as death or cerebral palsy or Bayley composite cognitive/motor scores <–2 SDs at 24 months corrected age.

Results

Outcomes were assessed in 113 of 126 infants. The composite adverse outcome was seen in 20 of 58 infants (35%) in the low threshold group and 28 of 55 (51%) in the high threshold (P = .07). The low threshold intervention was associated with a decreased risk of an adverse outcome after correcting for gestational age, severity of intraventricular hemorrhage, and cerebellar hemorrhage (aOR, 0.24; 95% CI, 0.07-0.87; P = .03). Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference, −0.06; 95% CI, −0.09 to −0.03; P < .001) at term-equivalent age. Infants in the low threshold group with a ventriculoperitoneal shunt, had cognitive and motor scores similar to those without (P = .3 for both), whereas in the high threshold group those with a ventriculoperitoneal shunt had significantly lower scores than those without a ventriculoperitoneal shunt (P = .01 and P = .004, respectively).

Conclusions

In a post hoc analysis, earlier intervention was associated with a lower odds of death or severe neurodevelopmental disability in preterm infants with progressive posthemorrhagic ventricular dilatation.

Trial Registration

ISRCTN43171322.

Le texte complet de cet article est disponible en PDF.

Keywords : Hydrocephalus, neurodevelopmental outcome, posthemorrhagic ventricular dilatation, preterm

Abbreviations : BSID-II, BSITD-III, CA, CP, ELVIS, FOHR, IVH, RCT, VP shunt, MRI, DRIFT

Plan

Methods

Neuroimaging Protocol and Assessment

Neurodevelopmental Assessment

Statistical Analyses

Results

Outcomes

Outcomes in Relation to Term-Equivalent Age MRI Variables

Discussion

	The authors declare no conflicts of interest.
	Portions of this study were presented at the Pediatric Academic Societies annual meeting, April 24-May 1, 2019, Baltimore, Maryland.

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Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years - 22/10/20

Abstract

Objective

Study design

Results

Conclusions

Trial Registration

Plan

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