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

Mantovani 1980.

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
  • Hydrocephalus was defined as 2 CT scans with progressively enlarging ventricles.

  • Placement of VPS.

  • Death before discharge from hospital.

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