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. 2017 Feb 16;2017(2):CD008435. doi: 10.1002/14651858.CD008435.pub3

Kostandy 2008.

Methods Randomized cross‐over trial
Participants Only 10 infants (30 to 32 weeks' PMA) enrolled
Postnatal age, range, days: 2 to 9
Birth weight, mean ± SD, grams: 1577 ± 327.00
Painful procedure: heel lance
Study period: unclear
Interventions Intervention: 30 minutes of skin‐to‐skin care before and during painful procedure
Control: standard care during painful procedure
Provider: mother provided skin‐to‐skin care
Outcomes Cry duration at baseline, warming, heel stick, and recovery
Notes Country: United States
Power calculation: yes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomisation was by permuted block design to ensure highest possible equivalence among infants."
The system of randomization is not mentioned
Allocation concealment (selection bias) Unclear risk Unclear
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk "Independent scorers of the videotapes were blind to the purpose and cross‐over design of the study."
Not clear if mothers' skin/breasts could be noted by researchers
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "All mothers who were approached agreed to participate."
Selective reporting (reporting bias) Low risk Outcomes listed in methods match those reported
Other bias Low risk "26 subjects were needed to detect moderate difference in crying time; however, funding permitted recruitment of only 10 subjects."
24 hour between procedures ‐ carry‐over effect: "Heel sticks were done by a consistent neonatal phlebotomist who used the National Association of Neonatal Nursing's standardized heel stick procedure with a Tenderfoot(TM) spring‐loaded lancet."