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 |
|
|
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.