Codipietro 2008.
| Methods | Randomised controlled trial I. Masking of randomisation ‐ low risk II. Masking of intervention high risk III. Masking of outcome assessment ‐ low risk IV. Completeness of follow‐up ‐ low risk | |
| Participants | 101 full‐term infants at more than 60 hours of age undergoing heel lance for metabolic screening Exclusion criteria: at‐risk pregnancy, medical instability, birth in general anaesthesia, maternal use of opioids, administration of naloxone or phenobarbital in the previous 48 hours and artificial feeding Group 1: 51 neonates Mean (range) GA ‐ 39.3 (+/‐ 1.2) weeks Mean (range) BW ‐ 3318 (+/‐ 402) grams Group 2: 50 neonates Mean (range) GA ‐ 39.4 (+/‐ 1.1) weeks Mean (range) BW ‐ 3308 (+/‐ 430) grams | |
| Interventions | Group 1: Breastfeeding Group 2: 1ml of 25% sucrose Infants in group 1 were held by mother and breast fed until there was a continuous active suction prior to heel lance. Group 2 infants were laid on a changing table and a bolus of 1 ml of 25% sucrose solution was administered through syringe in the mouth 2 minutes before the heel lance |
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| Outcomes | PIPP scale, changes in heart rate and saturation 30 seconds after the procedure, duration of first cry, percentage of crying in the first 2 minutes after the procedure | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Randomisation was done by using a computer random number generator. Allocation was concealed using opaque, sealed envelopes, which were opened sequentially by the paediatric nurse who performed blood sampling |
| Blinding (performance bias and detection bias) All outcomes | High risk | Incomplete blinding as breastfeeding group was held by mother while group 2 infants were laid on a changing table. Assessment of one of the outcomes (cry behaviour) was masked as it was assessed by 2 assistants who listened to tape recordings |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants were accounted for in the analysis of outcomes |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported on |
| Other bias | Low risk | Protocol available. All prespecified outcomes addressed |