Methods |
Open randomised clinical trial |
Participants |
Preterm infants with grade 3 or 4 intraventricular haemorrhage (IVH) on ultrasound scan |
Interventions |
Daily lumbar puncture starting at 7 to 10 days. Cerebrospinal fluid (CSF) was drained until flow stopped. Lumbar punctures were continued until the ventricular size decreased, remained unchanged for 2 consecutive weeks, or if the infant developed hydrocephalus requiring a ventricular drain or shunt. |
Outcomes |
Hydrocephalus, defined as a progressive increase in ventricular size as measured by ultrasound, in association with either signs of increased intracranial pressure (ICP) or an increase in head circumference > 2 cm/week for at least 2 weeks.
Shunt or ventricular reservoir.
Death before discharge from hospital.
Death.
|
Notes |
This trial used a random number table for 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 reported that the ultrasonographers were blinded to study classification. However, the trial defined hydrocephalus as an outcome by ultrasound and clinical signs of raised ICP. The trial authors did not give any information as to whether the assessors of the clinical signs of raised ICP were blinded to treatment allocation. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The trial included almost all participants to the end of the trial. |
Selective reporting (reporting bias) |
Low risk |
The trial authors reported on the main outcomes of hydrocephalus, death, and shunt placement. The trial did not test the neurodevelopmental outcome. |
Other bias |
Low risk |
No other sources of bias identified |