| Methods |
Randomised controlled trial
I. Masking of randomisation ‐ low risk
II. Masking of intervention ‐ high risk
III. Masking of outcome assessment ‐ not done for outcome recorded on video camera (cry duration, percentage time crying), outcomes on monitors (heart rate, saturation, blood pressure) were masked
IV. Completeness of follow‐up ‐ low risk |
| Participants |
96 stable full‐term newborn infants undergoing routine newborn screening (heel lance) were randomly assigned to one of the 3 treatment groups
Group 1: 32 neonates
Mean (range) age at procedure ‐ 37 (9) hours
Male: Female ‐ 13: 19
Group 2: 39 neonates
Mean (range) age at procedure 36 (8) hours
Male: Female ‐ 13:26
Group 3: 25 neonates
Mean (range) age at procedure 38 (14) hours
Male: Female ‐ 12:13 |
| Interventions |
Group 1: Breastfeeding
Group 2: Held by mother with use of pacifier
Group 3: Held by research assistant with the use of pacifier |
| Outcomes |
Percentage of infants cried
Proportion of cry time
Heart rate, blood pressure and oxygen saturation change before and after the procedure |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Adequate. Randomisation was done by blindly drawing a card from an envelope containing equal numbers of cards with letters representing each group |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Masking of intervention was not possible since it involved breastfeeding throughout the procedure. Masking of outcome assessment was not done |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Blood pressure measurements were not obtained in all infants, the authors comment that this was due to occasional malfunction of blood pressure equipment |
| Selective reporting (reporting bias) |
High risk |
Heart rate and oxygen saturation were secondary outcomes that were not reported on. Authors comment that there was no significant differences amongst the groups, but no data is given. Also, five babies were dropped from the study, according to the authors due to either excessive difficulties with equipment or 2 of them due to excessive physiologic instability |
| Other bias |
Unclear risk |
Protocol not available to compare |
