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. 2016 Nov 25;2016(11):CD003519. doi: 10.1002/14651858.CD003519.pub4

Nimbalkar 2014.

Methods Randomized controlled trial.
Participants 100 healthy full‐term or late preterm infants mean GA 37.7 + 1.35 weeks, birthweight 2605.6 + 419.8 g and their mothers delivering vaginally at Shree Krishna Hospital in Karamsad, North India.
Inclusion criteria: stable with birthweight > 1800 g, vaginal delivery.
Exclusion criteria: cesarean section, in need of resuscitation at birth, congenital malformations.
Interventions 1) In the SSC group (n = 50), initial care was performed under a radiant warmer. SSC began 30 min. to 1‐hour post birth and continued for 24 hours with a minimum of interruptions.
2) Infants in the control group (n = 50) received the same care as the SSC group except that they were dressed, head covered with a cap and back by a blanket when they were returned to their mothers. The postpartum maternity care wards were not climate controlled.
Outcomes HR, axillary temperature, episodes of hypothermia.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was done using web based software (WINPEPI).
Allocation concealment (selection bias) Low risk Selection cards were sealed in opaque envelopes. Mothers signed an informed consent and then were randomized to groups.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel could not be blind to group assignment.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome data (axillary temperature, HR, episodes of hypothermia) were collected during the intervention period so the assessors could not be blind to group assignment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 100 infants were randomized to groups (50 in each group) and data from all infants was analyzed.
Selective reporting (reporting bias) Low risk No outcome data were provided for HR except to state in the abstract that the HR was normal in both groups, however, the focus of the study was on incidence of hypothermia.
Other bias Low risk Baseline clinical characteristics of the 2 groups (mean GA, birthweight, HR, temperature, incidence of low birthweight) were similar in the 2 groups.