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. 2017 Apr 6;2017(4):CD000216. doi: 10.1002/14651858.CD000216.pub2

Ventriculomegaly 1990.

Methods Open randomised multicentre clinical trial at 15 neonatal intensive care units in England, Ireland, and Switzerland. Randomisation by telephoning and registering the infant before hearing the allocation.
Participants Neonates with IVH, with progressive increase in ventricular size and whose ventricular width had increased to 4 mm over the 97th centile.
Interventions Repeated lumbar puncture taking as much CSF as possible, maximum 2% body weight, carried out daily or less frequently to prevent further increases in ventricular size. If not more than 2 mL of CSF could be obtained, ventricular tapping was carried out in the same way and often enough to hold the ventricular width constant.
Outcomes
  • Permanent shunting if there was failure to control head size despite medical management or if repeated tapping was necessary for more than 4 weeks.

  • Death.

  • Placement of VPS.

  • Neurodevelopmental assessment at 12 months post‐term.

  • Neurodevelopmental status at 30 months by a developmental paediatrician.

Notes The developmental paediatrician that assessed the survivors at 12 and 30 months was blinded to early treatment allocation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial used a telephone method to allocate participants to treatment.
Allocation concealment (selection bias) Low risk The trial used a telephone method to allocate participants to treatment.
Blinding (performance bias and detection bias) 
 All outcomes Low risk The developmental paediatrician that assessed survivors was blinded to treatment allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At 12 months follow‐up, 3/79 children in the early tapping group and 3/78 children in the conservative group were lost to follow‐up. By 30 months, a further 3 in the early tapping group and 4 in the conservative management group were lost to follow‐up. This small proportion of missing data is unlikely to have significantly biased the outcome.
Selective reporting (reporting bias) Low risk The trial authors reported the main outcomes of interest: death, hydrocephalus, shunt placement, and disability.
Other bias Low risk No other sources of bias identified

Abbreviations: CT: computed tomography; ICP: intracranial pressure; IVH: intraventricular haemorrhage; PHH: posthaemorrhagic hydrocephalus; RCT: randomised controlled trial; VPS: ventriculoperitoneal shunt.