McFadden 2012.
| Methods | Open‐label, randomised, controlled trial | |
| Participants | 29 infants (11 intervention and 18 control) Inclusion criteria: gestational age 26 to 34 weeks, admission to NICU, intubation and mechanical ventilation, support with nasal continuous positive airway pressure (NCPAP) Exclusion criteria: age > 24 hours, major congenital anomalies, infants diagnosed with infection in the first 24 hours of life or born to mothers with active infection, parental refusal, mothers not speaking English, mothers not wishing to breastfeed Setting: The Woman’s Hospital of Texas, Houston, Texas, USA. From August 2011 to January 2012 |
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| Interventions | Oral care (gentle swirl of swab along inside of mouth ‐ wiping cheeks, tongue, palate, and lips every 3 to 6 hours, or more often as indicated) using colostrum/human milk (intervention) or sterile water (control A) or normal saline (control B) | |
| Outcomes | Oral colonisation (oral culture) and time to oral colonisation Necrotising enterocolitis (diagnostic criteria not specified) Ventilator‐associated pneumonia (diagnosed by increasing oxygen or ventilatory requirement and X‐ray changes) Duration of antibiotics (days) Days to reach full enteral feeds Length of hospital stay (days) Chronic lung disease (diagnostic criteria not specified) |
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| Funding source | The Woman’s Hospital of Texas, USA | |
| Notes | No protocol was available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Once consent was signed, a study envelope was drawn for randomization and a study number was assigned" No other detail of the randomisation methods were given |
| Allocation concealment (selection bias) | Low risk | "by drawing an envelope with the designation sealed inside" and "Once consent was signed, a study envelope was drawn for randomization and a study number was assigned" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The study was not blinded "Staff were informed whether the subject was assigned as control group A (sterile water) or B (normal saline) or group C (treatment: colostrum/human milk), assigned group was documented on the patient kardex in the chart and a sign placed on the infants chart to indicate study participation and the assigned group" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | The study was not blinded "Staff were informed whether the subject was assigned as control group A (sterile water) or B (normal saline) or Group C (treatment: colostrum/human milk), assigned group was documented on the patient kardex in the chart and a sign placed on the infants chart to indicate study participation and the assigned group" |
| Blinding of outcome assessment (detection bias) Death before discharge to home | Low risk | The study was not blinded, but death is unlikely to be influenced |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Three infants were still in the hospital when the study was completed and were not included in the analysis |
| Incomplete outcome data (attrition bias) Length of hospital stay | High risk | Three infants were still in the hospital when the study was completed and were not included in the analysis |
| Selective reporting (reporting bias) | Unclear risk | No protocol was available |