Methods |
Open clinical trial with alternation of treatment |
Participants |
Infants weighing less than 2000 g with grade 2 or 3 IVH on computed tomography (CT) scan |
Interventions |
Daily lumbar punctures starting 24 hours after diagnosis of IVH. 3 to 5 mL CSF was removed daily. Lumbar punctures were continued until the CSF was clear and protein concentration was < 180 mg/dL. |
Outcomes |
|
Notes |
Not true randomisation. The trial authors did not state whether or not the observers of outcomes were blinded to early treatment allocation. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
The trial used an alternation method to assign participants to treatment. |
Allocation concealment (selection bias) |
High risk |
Alternation method, allocation method not concealed to researchers. |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
The trial authors did not state whether or not the outcome observers were blinded to treatment allocation. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The trial authors analysed almost all participants recruited to the trial. |
Selective reporting (reporting bias) |
Low risk |
The trial authors commented on the main outcomes of hydrocephalus, shunt placement, and death. The trial did not test neurodevelopmental outcomes. |
Other bias |
Low risk |
No other sources of bias identified |