Beker 2017a.
| Methods | Randomised controlled pilot trial | |
| Participants |
Inclusion criteria: tube‐fed infants with a postmenstrual age of less than 29 weeks, admitted to the Neonatal Intensive Care Unit and who had not yet received regular feeds (2‐hourly) for more than 24 hours. Exclusion criteria: any major congenital anomaly and infants with birth weight below the 10th centile measured on Fenton Growth Charts. Sample size: 51 preterm infants (treatment group (n = 28) and control group (n = 23)). Setting: neonatal intensive care unit in Melbourne, Australia. Timing: March 2014 to April 2015. |
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| Interventions |
Intervention: smell and taste of human milk (own mother’s milk or pasteurised donor breast milk) before each tube feeding. Smell was provided by placing a gauze swab soaked with milk close to infants' nostrils. Taste was provided by offering a cotton wool bud soaked in milk for sucking. Control: no oral administration of milk until 32 weeks' gestation. |
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| Outcomes |
Primary outcome: time from birth to full enteral feedings (in days), defined as enteral volume of 120 mL/kg/day sustained for at least 24 hours. Secondary outcomes: death; type of milk feeds at 36 weeks' postmenstrual age; postmenstrual age at removal of nasogastric tube; necrotising enterocolitis; spontaneous intestinal perforation; duration of any parenteral nutrition in days; postmenstrual age at discharge to home; weight and weight z‐scores at birth, 28 days, 36 weeks’ postmenstrual age and at discharge; time with high‐flow nasal prongs or nasal intermittent positive airway pressure and time with endotracheal ventilation in hours; any intraventricular haemorrhage and intraventricular haemorrhage higher than grade 2; any retinopathy of prematurity and retinopathy of prematurity higher than stage 2 in any zone; presence of chronic lung disease; persistent ductus arteriosus requiring treatment; bacterial sepsis diagnosed after 48 hours of life. |
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| Notes |
Funding: pilot trial funded by Research Foundation for Women and Babies and Research grant from the Mercy Hospital for Women, Melbourne, Australia. Conflict of interest: none declared. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sequence generation was determined using a computer‐generated random‐number table. |
| Allocation concealment (selection bias) | Low risk | Treatment allocation was determined using sequentially numbered, opaque, sealed envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors were not blinded but are unlikely to have influenced the outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was randomised to the control group and later excluded because they did not meet the inclusion criteria for the trial. However, analysis was performed on intention‐to‐treat and therefore exclusion is unlikely to have influenced the outcome. |
| Selective reporting (reporting bias) | Low risk | All outcomes have been reported. |
| Other bias | Low risk | No significant differences for baseline characteristics between groups and no losses to follow‐up. |