Mehmet N Cizmeci1, Floris Groenendaal2, Kian D Liem3, Ingrid C van Haastert2, Isabel Benavente-Fernández4, Henrica L M van Straaten5, Sylke Steggerda6, Bert J Smit7, Andrew Whitelaw8, Peter Woerdeman9, Axel Heep8, Linda S de Vries10. 1. Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands; Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada. 2. Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands. 3. Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, the Netherlands. 4. Department of Neonatology, 'Puerta del Mar' University Hospital, Cadiz, Spain. 5. Department of Neonatology, Isala Women and Children's Hospital, Zwolle, the Netherlands. 6. Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands. 7. Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, the Netherlands. 8. Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom. 9. Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, the Netherlands. 10. Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands. Electronic address: l.s.devries@umcutrecht.nl.
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.
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.
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