Skip to main content
. 2011 Oct 5;2011(10):CD001452. doi: 10.1002/14651858.CD001452.pub4

Shah 1997.

Methods Randomized controlled trial
 Blinding of randomisation: Can't tell
 Blinding of intervention: No
 Complete follow up: Yes
 Blinding of outcome measurement: No
Participants Healthy neonates of > =37 weeks PMA (n=27)
 Demographic data: Values are mean (SD) or number (%)
HL group:
 Age (days) 3.1 (1.1)
 Sex (% male) 8 (57%)
 State (% awake before procedure) 5 (36%)
 Reason for test (% bilirubin) 13 (93%)
VP group:
 Age (days) 2.8 (1.2)
 Sex (% male) 8 (62%)
 State (% awake before procedure) 7 (58%)
 Reason for test (% bilirubin) 12 (97%)
Interventions VP (n=13)
 HL (n=14)
 0.25 ml of blood was obtained with either method
Outcomes Pain assessments were made using Neonatal Infant Pain Scale (NIPS)
 Parental rating of their own anxiety was assessed using a three point scale where 0= not worried at all, 1= a little worried and 2= very worried and infant's pain using a scale where 0= no pain at all, 1= a little pain and 2= a lot of pain
Notes One investigator (well‐trained paediatrician) performed all procedures
 One infant in each group had the procedure performed while being breat fed
 One of the reviewers (V. Shah) for this systematic review is the primary author of this paper
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias) 
 All outcomes High risk Personnel knew group assignment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes reported for all 27 infants included
Selective reporting (reporting bias) Unclear risk The study was not registered in a trials registry
Other bias High risk  The study was stopped after 27 infants had been enrolled from the preset sample of 50 infants