| Methods |
Phase 1 of Fanaroff 1994, placebo‐controlled |
| Participants |
1218 infants with BW 501 to 1500 g and randomly assigned at a mean age of 44 ± 25 hours after birth
8 centres in the US
January 1, 1988 to March 31, 1991 (or through April 1991) |
| Interventions |
In phase 1
595 infants received IVIG (Sandoglobulin, Sandoz Pharmaceuticals, East Hanover, NJ)
623 infants received placebo－equal volume of 5% albumin solution in the same vehicle prepared by the manufacturer of the immune globulin. The infants received their first dose of study drug within 24 hours of randomisation. To achieve a target level of 700 mg of immune globulin/dL, infants weighing 501 to 1000 g were given 900 mg of immune globulin per kg of body weight, and infants weighing 1001 to 1500 g were given 700 mg per kg. The infusions were repeated every 2 weeks until the infants weighed 1800 g, were transferred to another hospital, died or were sent home |
| Outcomes |
Sepsis (symptoms compatible with infection and a positive blood culture for bacteria or fungi obtained at least 96 hours after birth and before 120 days of life; for commensals, the diagnosis required 2 positive blood cultures obtained no more than 4 days apart)
The diagnosis of meningitis required a positive culture of CSF. The diagnosis of urinary tract infection required a pure culture from urine obtained by catheterization or suprapubic puncture
Proven infection (including septicaemia, meningitis or urinary tract infection) during the first 120 days of life
NEC (Bell's modified classification)
BPD (not defined)
Days in hospital |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Multicentre, 2‐phase controlled trial. Phase 1 was placebo controlled and double blinded; phase 2 was not placebo controlled |
| Allocation concealment (selection bias) |
Low risk |
An unbiased coin design was used |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
All lots of IVIG and placebo were marked and recorded by code. A placebo was used in phase 1 |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcomes reported for all randomly assigned infants |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol for the study was not available to us, and we therefore cannot tell if there were any deviations |
| Other bias |
Low risk |
Appears free of other bias |
