Of all the parameters for assessing the effectiveness and safety of phototherapy in the management of neonatal hyperbilirubinemia, none is as unambiguous as death. Although death rates are definitive, any relationship to the treatment modality or lack thereof may be confounded by other events. No prior data suggest the possibility of either enhanced or reduced mortality in infants treated with phototherapy.34,50
The groups were allocated randomly and the care given the two groups was the same, with the exception that one group received phototherapy. It was stipulated that research protocol requirements were at no time to take precedence over the medical care needs of the infant.
Seventy-two (10.7%) of the 672 newborns entered into the phototherapy group and 62 (9.3%) of the 667 newborns in the control group died during the first year of life. During the period prior to discharge from the nurseries, there were 68 (10.1%) deaths in the phototherapy group and 51 (7.6%) in the control group. All of the deaths except one in each group were in newborns who weighed less than 2,000 g at birth. These differences, as well as deaths in the first seven or 28 days of life, were not significantly different (X2 with Yates correction) when P < .05 was taken to be the upper level of significance (Table 1).
DEATHS BY BIRTH WEIGHT SUBGROUPS
The number of newborns entered into each study group and the deaths prior to discharge from the hospital for the birth weight groups 1,000 g or less and 1,001 to 1,999 g are indicated in Table 2.
- Copyright © 1985 by the American Academy of Pediatrics