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Published on: June 12, 2021
Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation:
Mehmet N Cizmeci1, Floris Groenendaal2, Kian D Liem3
1Department 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.
Insights
Early intervention for ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation may reduce the risk of death or severe neurodevelopmental disability. A low threshold for intervention showed promising results in a recent clinical trial.
Area of Science:
- Neonatalogy
- Pediatric Neurology
- Developmental Pediatrics
Background:
- Posthemorrhagic ventricular dilatation is a serious complication in preterm infants.
- Determining the optimal timing for intervention is crucial for improving outcomes.
Purpose of the Study:
- To compare the impact of early versus delayed intervention for ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation.
- To assess the effect of intervention thresholds on death or severe neurodevelopmental disability.
Main Methods:
- A multicenter randomized controlled trial involving lumbar punctures initiated at either a low or high threshold for ventriculomegaly.
- Outcomes included death, cerebral palsy, and neurodevelopmental scores at 24 months corrected age.
Main Results:
- The composite adverse outcome occurred in 35% of the low threshold group versus 51% in the high threshold group (P=0.07).
- Low threshold intervention was associated with a significantly decreased risk of adverse outcomes (aOR, 0.24; P=0.03) after adjustment.
- Infants with favorable outcomes had a smaller fronto-occipital horn ratio at term-equivalent age.
Conclusions:
- Earlier intervention for progressive posthemorrhagic ventricular dilatation in preterm infants may be associated with reduced odds of death or severe neurodevelopmental disability.
- This suggests a potential benefit of a lower threshold for initiating treatment.
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.
