Outcomes of extremely low-birth-weight infants between 500 and 750 g.

OBJECTIVE: The purpose of this study was to describe morbidity, mortality, and developmental outcomes among extremely low-birth-weight infants (500-750 g). STUDY DESIGN: This retrospective cohort study included 167 live-born infants born at Long Beach Memorial Medical Center between January 1990 and December 1995. RESULTS: Mortality rates were 86% among infants <600 g and 44% among those > or =600 g, and the rate decreased with increasing gestational age. The absence of chorioamnionitis (P =.01) and the use of antepartum corticosteroids (P <.0001) or neonatal surfactant (P =.0001) were associated with survival. Sixty-four percent of studied infants had respiratory distress syndrome, and 17% had grade III or IV intraventricular hemorrhage. Among the 63 survivors 57% were tested at 30 months of corrected age with the Bayley Scales of Infant Development. Mild or significant delays were seen on the mental development index in 68% of these cases and on the psychomotor development index in 58% of cases. CONCLUSION: Morbidity and mortality rates and the rate of developmental delay among infants with birth weights between 500 and 750 g were significant.

The effect of transport on the rate of severe intraventricular hemorrhage in very low birth weight infants.

OBJECTIVE: To determine the incidence of grade III or IV intraventricular hemorrhage in very low birth weight (VLBW) infants born at level I hospitals and transported to one tertiary center compared with those delivered at the same level III facility. METHODS: We evaluated all newborns admitted to a large tertiary neonatal intensive care unit from June 1, 1992, through December 31, 1995. All live born infants with birth weights of 500-1200 g and at least 24 weeks' gestation were included. Neonatal transports within 24 hours of delivery from 11 level I facilities were compared with those delivered at the same level III center with respect to grade III and IV intraventricular hemorrhage. Various antenatal and neonatal data were collected. RESULTS: Thirty-seven newborns (11%) experienced grade III or IV intraventricular hemorrhages among 329 who met study criteria. There were 27 cases (9%) in the 285 inborn neonates compared with 10 of 44 outborn cases (23%) (P < .02, 95% confidence interval 0.15, 0.87). The mean gestational age of the neonates with grade III or IV intraventricular hemorrhages was significantly lower in the inborn group, which further emphasizes the finding. No other study factors explained the difference. CONCLUSION: We found a higher risk for grade III or IV intraventricular hemorrhage developing in VLBW infants born at level I hospitals and transported to the tertiary care center compared with those born at the level III facility. This data should be considered when analyzing the potential effects of perinatal deregionalization.

Flare during drug withdrawal as a method to support efficacy in rheumatoid arthritis: amiprilose hydrochloride as an example in a double blind, randomized study.

OBJECTIVE: To evaluate the use of a randomized, double blind, drug withdrawal design as a means to test the efficacy of longterm therapy with antirheumatic drugs. METHODS: We evaluated 286 patients with rheumatoid arthritis (RA) treated with amiprilose hydrochloride for 1-3 years, with response, with or without other antirheumatic therapy, in a double blind, 12 week withdrawal study that compared patients randomized to continue amiprilose therapy vs patients randomized to placebo. The primary efficacy variable was preventing a predefined degree of clinical reactivation, or flare; the statistical tests of success were a difference in the proportion of flares and in the mean time to flare. RESULTS: Thirty percent of patients taking amiprilose and 43% of placebo patients experienced flare (p = 0.026). Patients taking amiprilose had a longer flare-free interval compared to placebo patients (p = 0.027), with the time to reactivation or flare becoming statistically different 73 days after withdrawal. CONCLUSION: Placebo controlled withdrawal designs are useful as evidence to support the longterm effectiveness of therapy in a proportion of patients with RA.

Is fluorescence polarization reliable and cost efficient in a fetal lung maturity cascade?

OBJECTIVE: The objective of the study was to compare the accuracy of the TDxFLM test (Abbott Laboratories) with the fetal lung maturity cascade (shake, foam stability index, lecithin/sphingomyelin tests) and to determine whether the TDxFLM test could increase the efficiency and reduce the cost without decreasing the reliability of a cascade. STUDY DESIGN: A prospective, single-blinded study was conducted. Uncontaminated amniotic fluid obtained by transabdominal amniocentesis for fetal lung maturity assessment was evaluated with use of the fetal lung maturity cascade and the TDxFLM test. At study completion the results of the TDxFLM test were compared with those of the maturity cascade with regard to hyaline membrane disease, which was defined by strict clinical and radiographic parameters. A power analysis was performed requiring a sample size of 100 infants delivered within 72 hours of amniocentesis with use of the 95% confidence interval. RESULTS: A total of 115 cases had a full maturity cascade performed, of which 40 (35%) had a positive shake or foam stability index and 75 cases required progression to a lecithin/sphingomyelin ratio because of negative results. The TDxFLM test result was > or = 70 mg/gm in 42 (37%) of these 115. One hundred eight newborns were delivered within 72 hours of the amniocentesis; 65% (71) of these were between 30 and 37 weeks of estimated gestational age. There were 7 cases of hyaline membrane disease in the 108 newborns. Of these 108, 87 had a mature original cascade versus 85 mature tests with use of a proposed TDxFLM test-lecithin/sphingomyelin ratio cascade with one case of respiratory distress syndrome and hyaline membrane disease. The sensitivity, specificity, and positive and negative predictive values for the original cascade were 86%, 84%, 27%, and 99%, respectively; for the proposed TDxFLM test-lecithin/sphingomyelin ratio cascade the values were 86%, 83%, 26%, and 99%, respectively. The TDxFLM test-lecithin/sphingomyelin ratio cascade would have resulted in a cost reduction of 24% with no significant delay in turnaround time. CONCLUSION: The TDxFLM test appears to be a reliable and accurate assessment of fetal lung maturity. Furthermore, by replacing the shake and foam stability index portion of the cascade with the TDxFLM test, a cost savings of 24% would occur without a decrease in safety. These results also reveal that it could enhance patient care and be cost efficient for institutions not currently doing fetal pulmonary maturity testing to undertake use of the TDxFLM test and to only send out specimens for a lecithin/sphingomyelin ratio that have an initial immature TDxFLM test result (< 70 mg/gm). Likewise, institutions currently only performing a lecithin/sphingomyelin ratio may consider a TDxFLM test-lecithin sphingomyelin ratio cascade. Although direct costs would increase, they would be counterbalanced by a significant reduction in laboratory technician time.

The efficacy and safety of auranofin compared to placebo in rheumatoid arthritis.

This double-blind multicenter study compares the effect of adding auranofin (AF) 3 mg bid or placebo to patients already taking nonsteroidal antiinflammatory drugs for rheumatoid arthritis. The 242 patients who completed 3 months of therapy demonstrated that the group receiving AF responded better than those receiving placebo. Of the 144 patients who completed 6 months coded medication, the efficacy in the AF group was superior to the placebo group in several parameters including a reduction in the number of painful or swollen joints, grip strength, dropout rate, and global efficacy as judged by the evaluating physician. A significant lowering of the Westergren erythrocyte sedimentation rate and immunoglobulin levels was noted in the AF treated patients. This study includes data summarizing the difference between both groups with respect to on-therapy conditions and toxicity.