| Methods |
Cross‐over design, quasi‐ randomized, order of subjects: randomization using replicated latin square design.
Blinding of randomization ‐ no
Blinding of intervention ‐ no
Complete follow up ‐ no
Blinding of outcome measure ‐ no |
| Participants |
15 preterm 32‐34 wks (mean 32.7 +‐1.3 SD), 2‐16 days age, results reflect 10 infants (four infants eliminated because of failure to establish thermal equilibrium within the time period of the study). One infant excluded because of tachycardia. |
| Interventions |
Cross‐over design, each infant own control, duration of study 3‐5 1/2 hr period depending on the time required to reach equilibrium.
Isolette infant incubator model, C‐86 double wall model. |
| Outcomes |
Oxygen consumption, body temperatures, heart rate and respiratory rate were measured.
Room air temperature and relative humidity, and incubator temperatures measured. |
| Notes |
4 infants excluded as they failed to establish thermal equilibrium within period of study. One infant excluded because of tachycardia to >175 bpm.
Experiments in the day, same section of the nursery. Duration of study periods (3‐5 hrs). VO2 measured during quiet sleep Temperature recorded every half hour, skin temp 6 sites, core temp mid esophagus. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Cross‐over design, quasi‐ randomized, order of subjects: randomization using replicated Latin square design. |
| Allocation concealment? |
High risk |
Blinding of randomization ‐ no |
| Blinding?
All outcomes |
High risk |
Blinding of intervention ‐ no
Blinding of outcome measure ‐ no |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Complete follow up ‐ no |
