| Methods |
Randomized controlled trial (blind drawing of 1 of 3 numbers with replacement). |
| Participants |
51 uncomplicated infants with gestation 38‐42 weeks, birthweight of at least 2500 g, normal labor and delivery and normal Apgar score. |
| Interventions |
Group 1 infants were suctioned, dried under a radiant heater for 5 min and then placed naked on the mother's bare chest for 25 min. The infant's back was then covered with 2 cotton blankets. Group 2 infants were placed naked directly on the mother's chest for 28 min after the umbilical cord was cut. Group 3 infants were placed under a radiant warmer without being placed on the mother's chest. |
| Outcomes |
Skin temperature measured on the infant's left side every 3 min for 45 min. Rectal temperature at 21 and 45 min. Outcomes were the number of infants with skin or rectal temperature in the neutral range at 21 or 45 min. |
| Notes |
Study was done in the USA. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Drawing numbers. |
| Allocation concealment (selection bias) |
Unclear risk |
Women were “randomly assigned to either the control group or to 1 of the experimental groups by blind drawing of 1 of 3 numbers, with replacement.” This suggests that group allocation could be changed by the investigator. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
"Both the couple and their caregiver were told how the baby would be handled after delivery.” |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Researcher collecting outcome data would also be aware of group assignment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Describe any loss of participants to follow‐up at each data collection point: It appeared that all women were accounted for at each data collection point. It was not clear if there was any missing data. |
| Selective reporting (reporting bias) |
Unclear risk |
Most outcomes appear to have been reported. |
| Other bias |
Unclear risk |
Authors reported that there were no significant differences between groups for a number of variables but the data were not shown. It was not clear how many of those eligible were approached to take part or whether recruitment only occurred at particular times (e.g. was the same researcher available at night and weekend) nor whether women who had long labors remained in the study. It is not clear whether women were excluded post randomization if there was any intrapartum problem. |
