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Treatment thresholds for intervention in posthaemorrhagic ventricular dilation: a randomised controlled trial
  1. Linda S de Vries1,
  2. Floris Groenendaal1,
  3. Kian D Liem2,
  4. Axel Heep3,
  5. Annemieke J Brouwer1,4,
  6. Ellen van ’t Verlaat4,5,
  7. Isabel Benavente-Fernández6,
  8. Henrica LM van Straaten7,
  9. Gerda van Wezel-Meijler7,8,
  10. Bert J Smit9,
  11. Paul Govaert5,
  12. Peter A Woerdeman10,
  13. Andrew Whitelaw3
  14. the ELVIS study group
    1. 1Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands
    2. 2Department of Neonatology, Amalia Children’s Hospital, Radboud University Medical Center, Nijmegen, The Netherlands
    3. 3Department of Neonatology, Southmead Hospital, School of Clinical Science, University of Bristol, Bristol, UK
    4. 4University of Applied Sciences Utrecht, Utrecht, The Netherlands
    5. 5Department of Neonatology, Erasmus Medical Center, Rotterdam, The Netherlands
    6. 6Neonatology Department, ’Puerta del Mar' University Hospital, Cadiz, Spain
    7. 7Isala Women and Children’s Hospital, Zwolle, The Netherlands
    8. 8Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands
    9. 9Directorate Quality & Patientcare, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands
    10. 10Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands
    1. Correspondence to Dr Linda S de Vries, Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children’s Hospital, University Medical Center Utrecht, 3508 AB Utrecht, The Netherlands; l.s.devries{at}umcutrecht.nl

    Abstract

    Objective To compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation.

    Design Multicentre randomised controlled trial (ISRCTN43171322).

    Setting 14 neonatal intensive care units in six countries.

    Patients 126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III–IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm).

    Intervention Cerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur.

    Composite main outcome measure VP shunt or death.

    Results 19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05).

    Conclusions There was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.

    • imaging
    • neonatology
    • preterm
    • post haemorrhagic ventricular dilatation
    • intraventricular haemorrhage

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    Footnotes

    • Contributors All authors and partners of the ELVIS study group. Enrolled patients in one of the 14 participating centres. Entered clinical data in the Electronic database. Had substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. Drafting the work or revising it critically for important intellectual content. Final approval of the version published. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Competing interests None declared.

    • Patient consent Parental/guardian consent obtained.

    • Ethics approval The study (ISRCTN43171322) was approved by the Medical Ethics Board Erasmus Medical Center Rotterdam.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Eight of 126 infants are also included in another paper. This is an observational study about posthaemorrhagic ventricular dilation, which is a present in press for Neurology. These data can be accessed when needed from the first author.

    • Collaborators The ELVIS study group: Han K; Division of Neuroscience, Department of Neurosurgery, University Medical Centre, The Netherlands, Steggerda S; Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands, Benders MJNL; Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands, Dudink J; Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; ter Horst HJ; Department Neonatology, UMCG, Groningen, The Netherlands, Dijkman KP; Department Neonatology, Máxima Medical Center, Veldhoven, The Netherlands, Ley D; Department Pediatrics, Institute of Clinical Sciences, Lund, Sweden, Fellman V; Department Pediatrics, Institute of Clinical Sciences, Lund, Sweden, de Haan TR; Department Neonatology, Emma Children’s Hospital, Academic Medical Center, University of Amsterdam, The Netherlands, Agut Quijano T; Department Neonatology, Hospital Sant Joan de Deu, Barcelona, Spain, Barcik U; Department Neonatology, Hospital Sant Joan de Deu, Barcelona, Spain, Mathur A; Division of Newborn Medicine, Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine, St Louis, USA, Graca AM; Department Neonatology, Hospital de Santa Maria, Lisbon, Portugal.

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