Bystrova 2003.

Methods	Randomized controlled trial (envelope with group assignment).
Participants	176 healthy full‐term infants and their mothers were divided into 4 treatment groups.
Interventions	All infants were immediately placed under a radiant warmer, dried, washed, weighed, given eye prophylaxis and cord care during the first 22 min post birth. 1) SSC group = 37 babies were placed prone and SSC on mother's bare chest for approximately 90 min and then roomed‐in (swaddled or dressed) on the maternity ward and breast fed on demand. 2) Mother's arms group = 40 babies were clothed (swaddled or dressed) and placed prone on their mother's bare chest for approximately 90 min and then roomed‐in on the maternity ward and breast fed on demand. 3) Nursery group = 38 babies were clothed (swaddled or dressed) and taken to the nursery immediately post birth and remained there while their mothers were on the maternity ward except for breastfeeding 7 times a day. 4) Reunion group = 38 babies were clothed (swaddled or dressed) and taken to the nursery immediately post birth, but roomed‐in with their mothers on the maternity unit and breast fed on demand.
Outcomes	Mean difference in infant axillary, interscapular, thigh temperatures and foot temperature change from 30 to 120 min post birth (Bystrova 2003). Amount of milk ingested (before and after breastfeeding infant weights), volume of supplemental feedings, number and duration of breastfeedings day 4 post birth, recovery of infant weight loss day 3‐5 post birth (reported in Bystrova 2007a). Number of breastfeedings, physiological breast engorgement, feeling low/blue days 1‐3 post birth, duration of nearly exclusive breastfeeding (reported in Bystrova 2007b). Maternal breast and axillary temperature, (reported in Bystrova 2007c). Assessment of mother‐child interaction at 12 months post birth using the PCERA (reported in Bystrova 2009).
Notes	Study was done in St Petersburg, Russia. Follow‐up Dumas 2012 reports: outcome – mother‐infant interaction during a breastfeeding on day 4 postpartum, analysis of 151 videotaped breastfeeding sessions, the outcome assessor was blind to the group assignment of the mothers and only 1 researcher coded the videos. An Assessment Tool for the Observation of Mother/Infant Interaction was developed for this study. It was evaluated for face and content validity as well as inter‐rater reliability by experts in the field. It examined behaviors such as the mother’s affective responsiveness to her infant, eye contact, stimulation of the baby, voice, patience and latch‐on attempts primarily on a 5‐point Likert scale from rough to soft. The researchers found that mothers in the SSC group were softer in their attempts to stimulate and latch their babies than those in the nursery separation group but had more nipple pain during latch (X² was the statistic).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An experimental 2 factor design (baby's location, apparel) was used. The randomization sequence was blocked for time and parity. Randomization to the 8 conditions occurred in blocks of 8 mothers independent of the other blocks and separated by parity.
Allocation concealment (selection bias)	Low risk	Informed consent was obtained during labor. Random assignment occurred immediately after birth. Sealed, numbered, opaque envelopes were opened sequentially. The research report stated that "both the researchers and the recruited women were blind to the task".
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind intervention.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The psychologists who evaluated videotaped mother‐child interactions at 12 months post birth using the PCERA were blind to group assignment. The videotaping was also performed by a psychologist who was blind to group assignment. No information was provided about whether the researchers who evaluated the other outcomes in these research reports were blind to group assignment. The evaluators of some of the outcomes, for example, infant temperatures taken during SSC, could not be blind to group assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	176 mothers were randomly assigned to the 4 main treatment groups. 23 mothers were excluded during their stay on the maternity ward for various reasons which were listed in the research report. There were no significant between‐group differences in background variables between the 23 mothers who were excluded and the 153 who remained in the study. 9 mothers were lost to follow‐up at 1 year. Reasons for their exclusion were provided. An additional 20 mother‐infant pairs were excluded from the PCERA assessments 12 months post birth. Reasons for their exclusion were provided.
Selective reporting (reporting bias)	Low risk	Numerical data were provided for all outcomes except recovery of infant weight loss day 3‐5 post birth (Bystrova 2007a) however, between the 4 groups, differences were reported to be insignificant. The results of the statistical tests and P values were reported for all outcomes in Bystrova, International Breastfeeding Journal, 2007). However, the M, SE was used instead of M, SD for the descriptive statistics. Data for the mean maternal axillary and breast temperatures were plotted on a graph for the 7 time points for data collection in Bystrova 2007c. The SE rather than the SD was used as the measure of dispersion. Data for the infant's foot and axillary temperatures were recorded in Bystrova 2003. Results of the statistical tests for the SSC group compared with the other groups were provided for 2/8 of the PCERA composite variables, child disregulation and irritability and dyadic mutuality and reciprocity. The results for the other composite variables were not reported but were stated as insignificant (Bystrova 2009). Additional statistical data were obtained from the researchers.
Other bias	Unclear risk	Data were reported using "per protocol" rather than "intention to treat" analysis.