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Treatment thresholds for intervention in posthaemorrhagic ventricular dilation: a randomised controlled trial
Linda S de Vries1, Floris Groenendaal1, Kian D Liem2
1Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Insights
A lower threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation did not significantly alter the rate of ventriculoperitoneal shunt placement or death. However, the lower threshold group underwent more invasive procedures, including lumbar punctures and reservoir insertions.
Area of Science:
- Neonatal Intensive Care
- Pediatric Neurology
- Clinical Interventions
Background:
- Posthaemorrhagic ventricular dilatation is a serious complication in preterm infants.
- Determining the optimal timing and threshold for intervention is crucial for improving outcomes.
Purpose of the Study:
- To compare the efficacy and safety of a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation.
Main Methods:
- A multicentre randomised controlled trial involving 126 preterm infants (≤34 weeks gestation) with grade III-IV intraventricular hemorrhage.
- Infants were randomised to either a low threshold (LT) or higher threshold (HT) for intervention based on ventricular index and anterior horn width.
- Interventions included cerebrospinal fluid tapping via lumbar punctures or ventricular reservoir, with ventriculoperitoneal shunt placement as a last resort.
Main Results:
- No significant difference was observed in the composite outcome of ventriculoperitoneal shunt placement or death between the LT and HT groups (19% vs 23%, P=0.45).
- Infants in the LT group required significantly more lumbar punctures (97% vs 58%, P<0.001) and reservoir insertions (62% vs 43%, P<0.05).
- A higher rate of shunt revision was noted in the LT group (58% vs 7%, P<0.01).
Conclusions:
- A lower threshold for intervention in posthaemorrhagic ventricular dilatation does not reduce the need for ventriculoperitoneal shunts or improve survival rates.
- The lower threshold approach leads to increased invasive procedures in preterm infants.
- Further assessment of neurodevelopmental outcomes is necessary to fully evaluate the long-term risks and benefits of each treatment strategy.
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.
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