Methods |
Cross‐over design, quasi‐ randomized, order of subjects: four infants studied first in each incubator.
Blinding of randomization ‐ no
Blinding of intervention ‐ no
Complete follow up ‐ yes
Blinding of outcome measure ‐ no |
Participants |
8 subjects
Birthweight 1440 ‐ 1890 g (median 1540g)
Gestational age 30‐35 (median 32 wk), AGA,
Age 6‐19 days (median 13.5d) |
Interventions |
Single vs double walled incubator. Isolette, Air Shields, Model C‐86. Skin temperature at servo‐control at 36.5oC.
2‐period cross‐over, own control. Each infant studied for two, 2 hour periods with 1 hour in between for stabilization.
Each infant studied during consecutive periods on the same day. |
Outcomes |
Oxygen consumption, carbon dioxide production, Body temperatures, heart rate and respiratory rate.
Metabolic heat production, heat loss, heat gain, were calculated. |
Notes |
Infants abdominal skin temperature servo controlled to 36.5 C
quiet, temperature controlled room. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Cross‐over design, quasi‐ randomized, order of subjects: four infants studied first in each incubator.
Blinding of randomization ‐ no |
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 |
Low risk |
Complete follow up ‐ yes |