| Methods |
Parallel randomised controlled trial |
| Participants |
434 low birth weight neonates: 800‐2000 grams. Ineligible if breast fed, or had severe congenital malformations, cardiac malformations and haemorrhage |
| Interventions |
Treatment commenced within 24 hours following birth
Intervention group: oral IgG/IgA 600 mg divided into ≥ 3 doses for 28 days. 211 neonates
Control group: no placebo used. Infants in control group were fed only infant formula or infant formula plus pasturized human milk. 223 neonates |
| Outcomes |
NEC assessed by pneumatosis intestinalis (no definition given) or free gas in peritoneum or portal venous tract or by histopathological examination of tissue obtained during surgery or autopsy |
| Notes |
No sample size estimation. Study was finished at a not prospectively defined point. 59% post randomisation exclusion rate in intervention and control groups |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Randomly allocated" to group A or group B. No other information provided |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding (no placebo) |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No information provided |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
59% loss post‐randomisation: 123 infants in the intervention group and 111 in the control group were withdrawn from the study within the first week because breast milk from their mothers became available. Infants withdrawn from the study were followed until the end of the 4th week of life for the possible development of NEC. 21 infants, all assigned to the control group, were excluded from evaluation because of incomplete protocols for the daily feeding regimen or mistakes in the protocols (e.g. a control child receiving IgA for a few days) |
| Selective reporting (reporting bias) |
Unclear risk |
We were unable to obtain the study protocol |
