| Study | Reason for exclusion |
|---|---|
| Alvarez 2016 | This study was found to be a non‐randomised trial upon translation of the report from Spanish |
| Lee 2015 | The mean age at which the study intervention was started was > 48 hours Double‐blind, placebo‐controlled, randomised controlled trial conducted in the NICU, Seoul National University Children's Hospital, in Seoul, Korea, including 48 infants born at < 28 weeks' gestation. Every 3 hours for 72 hours, 0.2 mL of colostrum or placebo (distilled water) was administered via the oropharyngeal route using opaque syringes. Reported outcomes included necrotising enterocolitis (defined as Bell's stage 2 or 3), which occurred in 4 of 24 in the colostrum group and in 6 of 24 in the control group; and proven sepsis, which occurred in 11 of 24 in the intervention group and in 14 of 24 in the control group. Three of the 24 infants in the intervention group died as compared to 6 of 24 in the control group. However, this study is not included in the review, as the study intervention was given after 48 hours of age to most participants |
| Montgomery 2008 | This was an observational study conducted to determine the feasibility of oropharyngeal administration to very low birth weight infants |
| Zhang 2017 | The mean age at which the study intervention was started was > 48 hours in both groups Double‐blind, placebo‐controlled, randomised controlled trial conducted in the NICU, Children's Hospital, Fudan University, in Shanghai, China. The study included infants with birth weight < 1500 grams who were transferred into the hospital within 24 hours after birth and parents who agreed to provide colostrum. Infants with a life‐threatening condition and any disease that influenced enteral feeding were excluded. Those in the intervention group received 0.1 mL of colostrum in each side of the cheek, and those in the control group received normal saline in a similar manner. Outcomes reported included necrotising enterocolitis (defined as Bell's stage 2 or 3) and late‐onset sepsis (defined as "bacterial growth occurred in at least one blood culture and symptoms of clinical sepsis"). NEC was reported in 1 out of 32 infants in the intervention group and in 5 out of 32 in the control group, and late‐onset sepsis occurred in 4 out of 32 in the intervention group and in 8 out of 32 in the control group. However, this study was excluded from the review as infants in both groups received the first dose of study medication (colostrum or normal saline) after 48 hours of life |
NEC: necrotising enterocolitis.
NICU: neonatal intensive care unit.