Table 3.
Study | Country | Sample size |
Average duration of hospitalization (days) |
Registered | Sequence generation & Allocation concealment |
Data collectors/outcome assessors blinded | Year last enrolled participant | Primary Outcome(s) | Comments | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Treatment | Control | Treatment | Control | ||||||||
Romeo et al.140 | Italy | 83 | 83 | 17.8 | 31.3 | No | The three arms had different dosing regimens and were, therefore, not concealed to the staff or families. | UTD | 2007 | Incidence of enteric fungal colonization and fungal and bacterial infections | Outcome category unclear but not primary |
Rojas et al.141 | Colombia | 372 | 378 | 20.0 | 20.0 | Yes (NCT00727363)‡ | Low risk | UTD | 2011 | Death or nosocomial infection | DOH stated as secondary outcome. Subgroup analysis demonstrated that this outcome was significant for infants with birth weight <1500 g. |
Oncel et al.143 | Turkey | 200 | 200 | 38* | 46* | Yes (NCT01531179)‡ | Low risk | Low risk | 2013 | NEC or death | DOH stated as secondary outcome |
Hernández-Enríquez et al.144 | Mexico | 24 | 20 | 39.3 | 50.6 | No | Low risk | The neonatologists who diagnosed and classified necrotizing enterocolitis knew the group allocation. | 2013 | NEC | Outcome category unclear but not primary |
Indrio et al.142 | Italy | 30 | 30 | 13.4* | 22.4* | Yes (NCT00985816)‡ | Low risk | Low risk | 2012 | Feeding tolerance | DOH stated as secondary outcome |
NA = not available.
UTD = unable to be determined based on information provided.
*Difference in outcome between treatment and control arms was significant.