| Methods |
Quasi‐randomised controlled trial
I. Masking of randomisation ‐ high risk
II. Masking of intervention ‐ low risk
III. Masking of outcome assessment ‐ low risk
IV. Completeness of the follow‐up ‐ low risk |
| Participants |
62 term infants undergoing heel lance blood sampling for screening tests
Exclusion criteria: preterm neonates, neonates with Apgar score < 7 at 5 minutes, neonates with low birth weight, sick neonates and neonates on any medication
Group 1: 20 neonates
Median (range) GA ‐ 39 (38 to 41) weeks
Median (range) BW ‐ 3300 (2800 to 4260) grams
Group 2: 21 neonates
Median (range) GA ‐ 39 (38 to 41) weeks
Median (range) BW ‐ 3510 (2750 to 4030) grams
Group 3: 21 neonates
Median (range) GA ‐ 40 (38 to 41) weeks
Median (range) BW ‐ 3300 (2800 to 4500) grams |
| Interventions |
All infants were fed 1 hour before the procedure
Group 1: 2 ml of foremilk
Group 2: 2 ml of hindmilk
Group 3: 2 ml of sterile water
The solutions were administered by syringe
Heel lance was performed 2 minutes after administration of the solution |
| Outcomes |
Crying time
Duration of first cry
Percentage change in heart rate at 1, 2 and 3 minutes
NFCS |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
High risk |
Inadequate. The authors provided further information on method of randomisation indicating that it was quasi‐randomised (based on number or day of the procedure) |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Authors do not comment on how the investigators were blinded, but they say the intervention was masked. The two investigators who analysed the data and the person who recorded video for the NFCS coding were unaware of the treatment allocation; hence, the outcome measure analysis was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All infants were accounted for in the analysis |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes are reported |
| Other bias |
Unclear risk |
Protocol not available to compare |
