Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation : Outcome at 2 Years
(2020) In Journal of Pediatrics 226. p.3-35- 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... (More)
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.
(Less)
- author
- contributor
- Ley, David
LU
and Fellman, Vineta
LU
- author collaboration
- organization
- publishing date
- 2020-11
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Cerebral Hemorrhage/complications, Cerebral Ventricles/pathology, Child, Preschool, Cohort Studies, Dilatation, Pathologic, Female, Humans, Infant, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases/psychology, Male, Neurodevelopmental Disorders/diagnosis, Spinal Puncture, Time-to-Treatment, Ventriculoperitoneal Shunt
- in
- Journal of Pediatrics
- volume
- 226
- pages
- 3 - 35
- publisher
- Academic Press
- external identifiers
-
- scopus:85090149877
- pmid:32800815
- ISSN
- 1097-6833
- DOI
- 10.1016/j.jpeds.2020.08.014
- language
- English
- LU publication?
- yes
- additional info
- Copyright © 2020 Elsevier Inc. All rights reserved.
- id
- c32c7b66-4c20-4844-bede-a7f3fa848608
- date added to LUP
- 2023-10-19 12:19:02
- date last changed
- 2024-04-19 03:37:28
@article{c32c7b66-4c20-4844-bede-a7f3fa848608,
abstract = {{<p>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.</p><p>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.</p><p>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).</p><p>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.</p><p>TRIAL REGISTRATION: ISRCTN43171322.</p>}},
author = {{Cizmeci, Mehmet N and Groenendaal, Floris and Liem, Kian D and van Haastert, Ingrid C and Benavente-Fernández, Isabel and van Straaten, Henrica L M and Steggerda, Sylke and Smit, Bert J and Whitelaw, Andrew and Woerdeman, Peter and Heep, Axel and de Vries, Linda S}},
issn = {{1097-6833}},
keywords = {{Cerebral Hemorrhage/complications; Cerebral Ventricles/pathology; Child, Preschool; Cohort Studies; Dilatation, Pathologic; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases/psychology; Male; Neurodevelopmental Disorders/diagnosis; Spinal Puncture; Time-to-Treatment; Ventriculoperitoneal Shunt}},
language = {{eng}},
pages = {{3--35}},
publisher = {{Academic Press}},
series = {{Journal of Pediatrics}},
title = {{Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation : Outcome at 2 Years}},
url = {{http://dx.doi.org/10.1016/j.jpeds.2020.08.014}},
doi = {{10.1016/j.jpeds.2020.08.014}},
volume = {{226}},
year = {{2020}},
}