| Methods |
Open randomised controlled trial
Blinding of randomization: unclear
Blinding of treatment: no
Blinding of outcome: no
Complete follow‐up: yes |
| Participants |
N of randomised patients = 16 (10 in treatment group, 6 in control group)
Infants with birthweights < 1500 g with IVH on ultrasound followed by i) enlargement of ventricular width to 5 mm over 2 SDs and ii) raised ICP defined as either an increase in ICP of 20 mm water or an absolute ICP exceeding 90 mm water. ICP was measured either by the Ladd fiberoptic non‐invasive method or by lumbar puncture. |
| Interventions |
i) Treatment group: Acetazolamide starting at 20 mg/kg/day iv or by mouth increasing by 10 mg/kg/day to 100 mg/kg/day together with furosemide at 1 mg/kg/day. Sodium citrate was started at 8 mEq/kg/day and adjusted to keep the serum bicarbonate > 18 mEq/L. If the posthemorrhagic hydrocephalus resolved after 3 months, acetazolamide was reduced by 25 mg/kg every 3rd day and furosemide was reduced by 0.25 mg/kg/day.
ii) Control group: Serial lumbar punctures initially daily then on alternate days. CSF was removed until free flow stopped. |
| Outcomes |
Ventriculoperitoneal shunt.
Nephrocalcinosis.
Death |
| Notes |
2 of the infants in the control group were treated with acetazolamide and furosemide before being shunted.
Patients recruited between November 1986 and October 1989. Results published in 1992 and 1999. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |