| Methods |
Open randomised clinical trial using random number tables |
| Participants |
Neonates with asymptomatic severe posthaemorrhagic hydrocephalus (PHH) |
| Interventions |
Daily lumbar punctures, taking enough CSF to lower the CSF pressure by half. Volumes ranged from 2 to 21 mL. Duration 1 to 3 weeks. |
| Outcomes |
Hydrocephalus management failure, defined as increasing head circumference, progressive decrease in cortical mantle (for example, occipital cortical mantle < 1 cm), signs of raised ICP. Placement of ventriculoperitoneal shunt (VPS). Death during follow‐up. Assessment at 3 to 6 years into no major handicap, single system disability, and multiple disability. |
| Notes |
The trial authors did not state whether the paediatric neurologists and the psychologist were blind to early treatment allocation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The trial used a random number table to allocate participants to treatment. |
| Allocation concealment (selection bias) |
Unclear risk |
The trial authors did not give any information regarding allocation concealment. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
The trial authors did not give any information regarding whether or not the observers of outcomes (neurologists and psychologist) were blinded to treatment group. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The trial included all children for the outcome of hydrocephalus management failure. Regarding neurodevelopmental follow‐up, 1/15 children in the close observation group were lost to follow‐up at 1 to 2 years. None of the 16 children in the LP group were lost to follow‐up. At 3 to 6 years, 1/15 children in the close observation group and 1/16 children in the LP group were lost to follow‐up. This small proportion of missing data is unlikely to have a significant bias to the outcome. |
| Selective reporting (reporting bias) |
Low risk |
The trial reported the main outcomes of death, hydrocephalus, shunt placement, and disability. |
| Other bias |
Low risk |
No other sources of bias identified |
