National Perinatal Information Center
National Perinatal Information Center


CLINICALLY RELATED STUDIES

Corticosteroid Dissemination Study
As part of the Agency for Health Care Policy Research's Low Birthweight PORT the University of Alabama studied the dissemination of Corticosteroids. NPIC subcontracted to collaborate on the data collection and analysis of the change in the use rates of corticosteroids. The design called for the enrollment of 20 NPIC member hospitals, 10 of whom agreed to participate in an educational effort for physicians aimed at promoting steroid use according to the NIH consensus conference guidelines. The analysis compared the education group to the control group pre and post education intervention. The data collection involved the abstraction of 6000 medical records. NPIC successfully enrolled 19 hospitals, participated in the design, created a data file from abstracted medical records, and collaborated on the analysis. Results of this study were published in JAMA in January, 1999.   » View the article's summary of reports

Implications of Surfactant for Mortality, Morbidity and Cost in Neonatal Intensive Care
This study was funded by the National Heart Lung and Blood Institute, and it assessed the impact of surfactant on mortality, morbidity and resource use on neonates 500 to 1,500 grams. The analysis used the NPIC Perinatal Center Data Base which contains clinical and financial data on all neonates admitted to fourteen member hospitals for six years (1985-1990). After the exclusion of multiple gestation, outborn infants, all infants in clinical trial years, 5,629 inborn singleton neonates remained in the analysis. Infants were then divided into a pre and post period based upon the date surfactant was approved for market use by the FDA.

This was the first epidemiological study to demonstrate the widespread influence of the impact of surfactant on a hospital population of newborns over time from three perspectives: mortality, morbidity and resource use. Logistic regression models, controlling the race, sex and birthweight, indicated a 31% reduction in mortality and a 21% reduction in respiratory morbidity, defined as a diagnosis of RDS, BPD or IE. The mortality findings clarified the debate concerning whether the drop in the U.S. infant mortality in 1990 could be attributed to surfactant. Applying birthweight specific rates adjusted for race and sex to the national statistics indicated that surfactant alone reduced the U.S. infants mortality rate by 5% or 80% of the total decline seen between 1989 and 1990. Resource use model which controlled for, birthweight, sex and race, indicated a $5,800 reduction in inflation adjusted average total charges per survivor. The resource use, morbidity and mortality findings together showed that despite the cost of the intervention itself surfactant is a cost effective intervention.

The study was expanded twice, once to add more recent data and the second time to analyze larger newborns, outborns and twins.

Original findings were published in the New England Journal of Medicine May 26th 1994. Findings from the Phase III work were published in "Pediatric Clinics of North America", Spring, 1998.

Implications of Surfactant for Mortality, Morbidity and Cost in Neonatal Intensive Care Phase II
"Implications of Surfactant for Mortality, Morbidity and Cost in Neonatal Intensive Care Phase II" was funded by the National Heart Lung and Blood Institute to expand on the original study which assessed the impact of surfactant on mortality, morbidity and resource use on neonates 500 to 1,500 grams. The Phase II component added additional years to the study and focused on exploring the nature of IVH and BPD morbidity in survivors. The Phase II analytic activities used the NPIC Perinatal Center Data Base which contains clinical and financial data on all neonates admitted to fourteen member hospitals for seven and a half years (1985-1992). After the exclusion of multiple gestation, outborn infants, all infants in clinical trial years, 7358 inborn singleton neonates remained in the analysis. Infants were then divided into a pre and post period based upon the date surfactant was approved for market use by the FDA.

This second phase of the study confirmed the original findings. Logistic regression models, controlling the race, sex and birthweight, indicated a 36% reduction in mortality and a 19% reduction in respiratory distress syndrome in survivors. In addition overall morbidity remained the same. Rates of IVH increased on both the original and the phase II analyses. Further exploration of these cases revealed that co-morbid conditions were less frequent and length of stay declined. Thus, even though IVH increased, the severity of the illness declined. Resource use models, birthweight, sex and race, indicated a $6,500 reduction in inflation adjusted average total charges per survivor. The resource use, morbidity and mortality findings together show that despite the cost of the intervention surfactant remains a cost effective intervention.

 
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