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1.
OBJECTIVES: To assess the risk of hospitalization associated with respiratory syncytial virus (RSV) and to estimate the economic impact of RSV prophylaxis with either RSV immune globulin (RSV-Ig) or RSV monoclonal antibody (palivizumab) on a cohort of preterm infants born at 32 weeks' gestation or earlier. DESIGN: Historical cohort study. SETTING: A 12-county neonatal network served by the regional center in Rochester, NY. PARTICIPANTS: One thousand twenty-nine infants born at 32 weeks' gestation or earlier followed up until 1 year of corrected age. MAIN OUTCOME MEASURES: Rate of hospitalization with an RSV-associated illness; cost per hospitalization prevented resulting from either form of RSV prophylaxis. RESULTS: The probability of hospitalization with an RSV-associated illness for infants born at 32 weeks' gestation or earlier was estimated at 11.2%. The incidence of RSV hospitalization increased with decreasing gestational age (13.9% vs 4.4% for infants born at < or =26 weeks' gestation vs those born at 30-32 weeks' gestation). Infants requiring respiratory support at 36 weeks of postconceptual age (PCA) or older had a higher hospitalization rate (16.8% vs 6.2%), longer hospital stays, and higher hospital charges than infants requiring respiratory support at less than 36 weeks of PCA. For infants requiring respiratory support at less than 36 weeks of PCA, the incidence of RSV hospitalization still increased with decreasing gestational age (10.2% vs 4.3% for infants < or =26 weeks' gestation vs those 30-32 weeks' gestation). Analysis indicated that both forms of RSV prophylaxis would increase the net cost of care for all groups. Palivizumab was more cost-effective than RSV-Ig for preventing RSV hospitalization among infants who required respiratory support at less than 36 weeks of PCA, especially those born at 26 weeks' gestation or earlier. Overall, RSV-Ig was more cost-effective than palivizumab for infants requiring respiratory support at 36 weeks of PCA or older. CONCLUSIONS: This analysis suggests that available forms of RSV prophylaxis would increase the net cost of care not only for the entire cohort but for each of the subgroups studied. However, the RSV hospitalization rate and the cost-effectiveness of prophylaxis varied markedly by subgroup.  相似文献   

2.
BACKGROUND: Alaska Native children experience extremely high rates of hospitalization for respiratory syncytial virus (RSV) infection. We evaluated the effect of palivizumab prophylaxis on the incidence of RSV hospitalizations in high risk Alaska Native children. METHODS: We analyzed two retrospective cohorts. The first analysis, of southwest Alaska Native children hospitalized with acute respiratory infections during 1993 to 1996 and 1998 to 2001, compared RSV hospitalization rates among premature and nonpremature infants born before (1993 to 1996) and after (1998 to 2001) palivizumab use. The second analysis, of Alaska Native infants with a history of prematurity or lung disease during 1998 through 2001, compared RSV hospitalization among children receiving palivizumab during protected periods (within 32 days after a dose of palivizumab) and unprotected periods. RESULTS: First RSV hospitalizations in premature infants from southwest Alaska meeting criteria for palivizumab prophylaxis decreased from 439 per 1000 births before to 150 per 1000 births after palivizumab (relative rate, 0.34; 95% confidence interval, 0.17 to 0.68), whereas the rate in nonpremature infants remained stable (148 per 1000 births compared with 142 per 1000). Among high risk Alaska Native children during 1998 through 2001, the rate of first RSV hospitalization was 0.55 per 1000 protected days and 1.07 per 1000 unprotected days (relative rate, 0.52; 95% confidence interval, 0.28 to 0.93). CONCLUSIONS: Palivizumab reduced RSV hospitalizations in high risk infants in a region with high rates of RSV hospitalization.  相似文献   

3.
BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of hospitalization in preterm infants and infants with chronic lung disease (CLD). Palivizumab, a humanized monoclonal antibody, was approved in Europe in 1999 as prophylaxis against severe RSV-related respiratory illness. No multiple season data have been published on palivizumab effectiveness in European populations. Data collected during 4 years in Spain compared RSV hospitalization rates and risk factors in a cohort of palivizumab-prophylaxed and nonprophylaxed preterm infants. METHODS: The first cohort was derived from 2 previous studies and included 1583 infants followed during 2 RSV seasons (1998 to 1999, 1999 to 2000) before palivizumab initiation in Spain. The second cohort included 1919 infants who received palivizumab prophylaxis for 2 subsequent respiratory seasons (2000 to 2001, 2001 to 2002). Both cohorts were preterm (< or =32 weeks gestational age) and < or =6 months old at onset of RSV season. RESULTS: The RSV hospitalization rate in the palivizumab-prophylaxed cohort was 3.95, and it was 13.25% in nonprophylaxed infants This 70% overall difference in RSV hospitalization was observed despite the palivizumab-prophylaxed group's lower gestational ages, more severe neonatal intensive care unit respiratory courses and higher incidence of CLD. Significant risk factors for RSV hospitalization in both cohorts included: lower gestational age; chronologic age <3 months at RSV season onset; school age siblings; and lower parental education. Nonprophylaxed children had a higher risk for RSV-related hospitalization than did prophylaxed patients (odds ratio, 3.86; 95% confidence interval, 2.83 to 5.25). CONCLUSION: Data from this study support the effectiveness of palivizumab in significantly modifying RSV-related hospitalizations in high risk preterm infants, with and without CLD, during two respiratory seasons.  相似文献   

4.
OBJECTIVE: To provide information on the use and outcomes of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus (RSV) infection. DESIGN: Observational, prospective, longitudinal, multicenter study. SETTING: Eighteen hospitals and pediatric clinics located in six provinces across Canada. PATIENTS: Infants enrolled in the palivizumab Special Access Programme of Canada's Therapeutic Products Programme throughout the 1999 to 2000 RSV season. Most were premature infants born at < or = 32 weeks of gestation and/or had bronchopulmonary dysplasia. METHODS AND MAIN OUTCOME MEASURES: Neonatal and demographic data were recorded for each subject. The parent/caregiver was contacted on a monthly basis until the end of the RSV season to obtain information on palivizumab utilization and compliance as well as incidence and severity of respiratory infections. RESULTS: There were 444 evaluable subjects who each received 1 to 7 injections of palivizumab for a total of 1702 doses from September 1999 to April 2000. Most subjects received 5 injections with high compliance. Prophylaxis was discontinued in 2% of children. There were 116 clinical events or hospitalizations involving respiratory tract infections reported in 91 children. Eighty-six of these were managed in an outpatient setting, and 30 required hospitalization. The estimated incidence of hospitalization for RSV-positive lower respiratory tract infections (LRTIs) was 2.4%. Hospitalization for RSV LRTI occurred more often in children with bronchopulmonary dysplasia (6.0%) than in those with prematurity only (1.6%). CONCLUSIONS: This study demonstrates that prophylaxis with palivizumab during the RSV season was associated with a low rate of hospitalization for RSV-positive LRTIs. Palivizumab was well-tolerated, and compliance was high. The findings confirm the results of the major randomized clinical trial of palivizumab and demonstrate the safety and effectiveness of RSV prophylaxis.  相似文献   

5.
Preterm infants are at increased risk of being rehospitalised during the first few months of life with severe respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) that usually manifests as apnea and hypoxemia. This occurs more commonly in preterm infants < 33 weeks gestational age (GA), but recent studies demonstrate that late preterm infants (those born between 34 weeks and 0 days to 36 weeks and 6 days GA) are equally susceptible to RSV LRTI as those with lower GA. Factors associated with severe LRTI include immaturity of both the humoral and cell-mediated immune system and interrupted lung development prior to 36 weeks GA which results in lower functional residual capacity, reduced compliance, diminished forced expiratory air flow and impaired gas exchange. Morbidity and mortality are significantly increased in late preterms compared to their term counterparts. Prophylaxis with palivizumab against RSV infection seems to be crucial. Due to the large number of infants in this age group, additional risk factors have been identified in order to tailor palivizumab prophylaxis effectively to those at highest risk for severe RSV LRTI.  相似文献   

6.
BACKGROUND: The efficacy of palivizumab prophylaxis after bronchopulmonary dysplasia (BPD) has been demonstrated in a single placebo-controlled trial. Concern has emerged about the degree of efficacy of palivizumab.This study was designed to determine the efficacy of administration of palivizumab to premature infants with a gestational age 相似文献   

7.
Aims: To register hospitalizations for respiratory syncytial virus (RSV) infections and estimate costs of prophylaxis with humanized monoclonal antibodies (palivizumab) against RSV, compared to hospital care, in cases with congenital heart defects (CHDs). Methods: Population based study with prospective registration of CHDs. Costs for hospital treatment of RSV-infections in CHD-patients calculated by means of the Norwegian Diagnosis Related Groups system. Results: In 43 470 infants live born in the population through the 18-year period 1987-2004 a structural CHD was diagnosed in 527 (1.2%). A total of 898 (2.1%) hospitalizations for RSV-infections occurred in the study population 1987-2005. The hospital admittance rate was significantly higher for CHD-cases (4.8%) than for children without CHD (2%) (P=0.002). Severe CHDs (need for surgery or catheter intervention) had a higher admittance rate (9.2%) compared to the group of remaining CHDs (3.3%) (P=0.01). Number needed to treat with palivizumab to avoid one hospitalization for RSV-infection in cases of severe CHDs was calculated to 24, at costs of US$ 195 000. The expenses for palivizuamab prophylaxis in severe CHDs were 31 times that of hospital treatment.

Conclusion: Prophylaxis with palivizumab in severe CHDs is not cost-effective.  相似文献   

8.
BACKGROUND: Infants born at 33 through 35 completed weeks of gestation (33-35GA) are at risk for severe respiratory syncytial virus (RSV) infection, and palivizumab prophylaxis lowers hospitalizations for RSV infection by as much as 80%. The 33-35GA cohort comprises 3-5% of annual births; thus expert panels recommend limiting prophylaxis to situations in which frequency or health care impact of RSV infection is high. This study sought to identify independent risk factors for hospitalization for RSV infection. METHODS: This was a multicenter, prospective, observational cohort study of 33-35GA infants followed through their first RSV season (2001/2002 or 2002/2003). Baseline data were collected by interview with parents and review of medical records. Respiratory tract illnesses were identified by monthly phone calls, and medical records were reviewed for emergency room visits or hospitalizations. Risk factors were determined by stepwise logistic regression. RESULTS: Of 1,860 enrolled subjects, 1,832 (98.5%) were followed for at least 1 month, and 1,760 (94.6%) completed all follow-ups. Of 140 (7.6%) subjects hospitalized for respiratory tract illnesses, 66 infants had proven RSV infection. Independent predictors for hospitalization for RSV infection were: day-care attendance (odds ratio, 12.32; 95% confidence interval, 2.56, 59.34); November through January birth (odds ratio, 4.89; 95% confidence interval, 2.57, 9.29); preschool age sibling(s) (odds ratio, 2.76; 95% confidence interval, 1.51, 5.03); birth weight <10th percentile (odds ratio, 2.19; 95% confidence interval, 1.14, 4.22); male gender (odds ratio, 1.91; 95% confidence interval, 1.10, 3.31); > or = 2 smokers in the home (odds ratio, 1.87; 95% confidence interval, 1.07, 3.26); and households with >5 people, counting the subject (odds ratio, 1.79; 95% confidence interval, 1.02, 3.16). Family history of eczema (odds ratio, 0.42; 95% confidence interval, 0.18, 0.996) was protective. CONCLUSIONS: Specific host/environmental factors can be used to identify which 33-35GA infants are at greatest risk of hospitalization for RSV infection and likely to benefit from palivizumab prophylaxis.  相似文献   

9.
OBJECTIVE: To establish the preterm infant hospitalization risks from respiratory syncytial virus (RSV) in New Zealand and the net cost per hospitalization averted by palivizumab. METHODS: The 437 infants born < 32 weeks' gestation in 1997 and treated at five major neonatal units were identified. Subsequent admissions during the next 2 years for bronchiolitis, pneumonia and croup were tracked, and information collected on RSV tests performed. Data on the length of stay and hospital costs were used to calculate the potential net cost per hospitalization averted associated with the use of palivizumab and the number needed to treat (NNT) to prevent one hospitalization. RESULTS: Estimated RSV readmission risk before 1 year corrected age in infants < 32 weeks' gestation discharged home on oxygen, and those " 28 weeks' gestation, or between 29 and 31 weeks' gestation with or without chronic lung disease was 42%, 23%, 19%, 10% and 8%, respectively. The NNT with palivizumab to prevent one hospitalization ranged from six to 26 across subgroups. Mean (range) net cost per hospitalization averted was 60,000 New Zealand dollars ($28,000-$166,700). In no subgroup would prophylaxis result in net cost saving. Prophylaxis for all NZ infants " 28 weeks' gestation would cost approximately $1,090,000 net and prevent 29 hospitalizations annually, being equivalent to $37,000 net per hospitalization averted, with eight infants treated to prevent one hospitalization. Alternative assumptions about cost and efficacy failed to alter these findings. CONCLUSION: If value is placed on preventing morbidity, the priority groups for palivizumab prophylaxis are preterm infants discharged home on oxygen, followed by preterm infants of 28 weeks' gestation or less.  相似文献   

10.
OBJECTIVES: To evaluate the cost-effectiveness of palivizumab as respiratory syncytial virus prophylaxis in premature infants without chronic lung disease and to evaluate the impact on cost-effectiveness of a potential reduction in risk of asthma following respiratory syncytial virus infection among infants receiving palivizumab. DESIGN: Two decision analytic models were designed, one with and the other without accounting for increased risk of asthma following respiratory syncytial virus infection. SETTING: A hypothetical community or university hospital. PARTICIPANTS: Hypothetical cohorts of infants without chronic lung disease born at 26 to 32 weeks' gestation. INTERVENTIONS: Palivizumab prophylaxis vs no prophylaxis. MAIN OUTCOME MEASURES: Expected costs and incremental cost-effectiveness ratio expressed as cost per quality-adjusted life-year. RESULTS: The expected costs were higher for palivizumab prophylaxis as compared with no prophylaxis. The incremental cost-effectiveness ratios were high for all gestations and are not considered cost-effective by today's standards (<$200 000 per quality-adjusted life-year). Both models were sensitive to variation in the cost of palivizumab. The model that included asthma was sensitive to variation in quality of life for children with asthma. In instances where asthma was considered severe with profound worsening in quality of life compared with life without asthma, some infants had an incremental cost per quality-adjusted life-year that was less than $200 000. CONCLUSIONS: Our model supports implementing more restrictive guidelines for palivizumab prophylaxis. Palivizumab was cost-effective for some infants in an analysis that accounted for increased risk of severe asthma following respiratory syncytial virus infection.  相似文献   

11.
Aim: To investigate the cost‐effectiveness of palivizumab vs. no prophylaxis for respiratory syncytial virus (RSV) infection in preterm infants in Sweden. Methods: A probabilistic Markov model was populated using a nationwide register linkage and data from the literature. Cost‐effectiveness was investigated from a societal perspective over a lifetime for infants born at <29 weeks of gestation. Palivizumab was modelled using assumptions for its direct effect on RSV hospitalization risk and an indirect effect (via decreased RSV hospitalization) on subsequent asthma and mortality during the epidemic. Costs and effects were discounted by 3%. Results: In the base case, prophylaxis resulted in an additional 0.102 quality‐adjusted life‐year (QALY) at a cost of 20 000 SEK relative to no prophylaxis (incremental cost‐effectiveness ratio [ICER] 195 000 SEK/QALY). The probability of prophylaxis being cost–effective was 99% at a willingness‐to‐pay of 500 000 SEK/QALY. Assumptions about a causal association between RSV infection and subsequent asthma had a moderate impact, while exclusion of the indirect prophylaxis effect on mortality increased the ICER to 492 000 SEK/QALY. When excluding both of these, prophylaxis was not cost–effective. Conclusion: Based on a willingness‐to‐pay of 500 000 SEK/QALY, palivizumab was found to be cost–effective compared with no prophylaxis for infants born at <29 weeks if severe RSV infection was assumed to increase subsequent asthma or mortality risk.  相似文献   

12.
OBJECTIVE: To determine the effect of an interventional program designed to improve adherence to American Academy of Pediatrics (AAP) guidelines for palivizumab prophylaxis. METHODS: The study was carried out at the Children's Hospital, University of California, Irvine Medical Center and its affiliated clinics. An interventional program focusing on education of health care workers on AAP guidelines, updating health care providers about respiratory syncytial virus (RSV) activity, as well as designating a single clinic with effective screening of referrals for administration of palivizumab, was implemented during the summer of 2004. The medical records of infants who had received at least 1 dose of palivizumab or were eligible to receive palivizumab during the 2003-2004 and the 2004-2005 RSV seasons at the University of California, Irvine Medical Center were reviewed. The proportion of patients who received injections according to AAP guidelines was compared. RESULTS: After the intervention, the proportion of patients who received palivizumab injections according to AAP recommendations increased from 39% to 61% (P < 0.0001). The program decreased the proportion of unnecessary injections significantly (140/525, or 27%, in 2003-2004 to 33/323, or 10%, in 2004-2005; P < 0.0001) but did not change the proportion of missing injections. The program resulted in a significant drop (14% to 2%; P < 0.0001) in proportion of palivizumab injections that were given too late, when RSV activity had subsided. RSV hospitalization rates did not change as a result of the intervention. CONCLUSIONS: Our interventional program improved adherence to AAP guidelines mainly by decreasing the unnecessary palivizumab injections.  相似文献   

13.
OBJECTIVE: To determine the impact of respiratory syncytial virus (RSV) prophylaxis among preterm infants of < or =32 weeks gestation by comparing the severity of illness and cost of RSV-related care during the two winter seasons before (1994 to 1995, 1995 to 1996) with the two seasons after initiation of prophylaxis (1996 to 1997, 1997 to 1998). METHODS: Preterm infants of < or =32 weeks gestation at risk for hospitalization with RSV infection were identified retrospectively from the infants hospitalized in our neonatal units. Infants were included if they (1) were born 6 months before or during four winter seasons (1994 to 1998), (2) were discharged from the neonatal unit and (3) had remained in the university outpatient clinic system during at least the first winter of life. Preterm infants of < or =32 weeks gestation hospitalized with RSV were identified from our RSV database (which includes cost of hospitalization, duration of hospital stay, pediatric intensive care unit stay and intubation). Infants receiving prophylaxis were identified prospectively. RESULTS: The incidence of hospitalization with RSV was significantly lower among the cohort of infants born after initiation of prophylaxis: 8.7% (17 of 195) vs. 22% (35 of 159), P = 0.00049 by two tailed Fisher's exact test. Among the cohort of infants born after initiation of prophylaxis (n = 195), 100 infants received prophylaxis. The gestational and chronologic ages of the prophylaxis-treated infants were significantly lower than those of the non-prophylaxis-treated infants (n = 95). The prophylaxis-treated infants also were more likely to have bronchopulmonary dysplasia. Only 1 (1%) of the prophylaxis-treated infants required hospitalization for RSV. Comparison of the cohort of infants born before initiation of prophylaxis to the cohort born after initiation of prophylaxis (includes prophylaxis-treated and non-prophylaxis-treated infants) revealed a significant reduction in severity of illness and cost. The length of stay in the cohort born before initiation of prophylaxis was reduced 83.8%: 373.6 days per 100 infants at risk vs. 60.5 (P = 0.00055). The length of stay in the pediatric intensive care unit was reduced 92.7%: 218.2 days per 100 infants at risk vs. 15.9 (P = 0.00029). The duration of intubation was reduced 95.6%: 187.4 days per 100 infants at risk vs. 8.2 (P = 0.00024). The dollars spent for RSV-related care (hospitalizations and prophylaxis) per 100 infants at risk for RSV was reduced 65% in the cohort of infants born after prophylaxis: $670,590 per 100 infants at risk vs. $234,596 (P = 0.00056). This reduction remained significant (64.9%) if the cost of ribavirin (drug and administration fees) was excluded from the cost of hospitalization. CONCLUSIONS: These data reveal that RSV prophylaxis significantly reduced the incidence of RSV hospitalizations and severity of illness as well as the cost of RSV-related care among these infants.  相似文献   

14.
BACKGROUND: A monoclonal antibody, palivizumab, directed against respiratory syncytial virus (RSV) has been shown to decrease hospitalisation rates. Because of its expense, the cost-effectiveness of this agent should be determined for high-risk groups. AIM: To determine characteristics of RSV infection in Townsville and the economic feasibility of palivizumab immunoprophylaxis in high-risk groups. METHODS: Cases of RSV-positive bronchiolitis were retrospectively identified. Cases were grouped according to recognised risk factors. The hypothetical costs of palivizumab immunoprophylaxis for infants at risk were calculated. RESULTS: The rate of hospitalisation with RSV-positive lower respiratory tract infection was 22 per 1000 live births but increased to 50 per 1000 among Indigenous babies born weighing <2500 g. The cost of preventing an admission in each of the identified high-risk groups, based on drug costs alone, ranged from AD 69,861 to AD 88,547. CONCLUSION: Palivizumab was not cost-effective in the prophylaxis of RSV in the high-risk group of infants tested here.  相似文献   

15.
The hospitalization rate for pandemic influenza A (H1N1)v 2009 of 150 prospectively followed, prematurely born infants did not differ significantly from that of term-born infants from the same geographical area (0.7% vs. 0.07%, P = 0.12), but was higher for other viral lower respiratory tract infections (5.3% vs. 0.6%, P < 0.0001). Pandemic influenza A H1N1 immunization uptake in the prematurely born infants was low (9.3%).  相似文献   

16.
BACKGROUND: Respiratory syncytial virus (RSV) remains a significant cause of morbidity, especially in premature infants and immunocompromised children, resulting in approximately 100 000 hospitalizations annually. A study was performed to evaluate the outcomes of those given palivizumab (Synagis; MedImmune, Inc., Gaithersburg, MD) during the 1998 to 1999 RSV season, its first season in general use. METHODS: A retrospective chart review of 1839 patients from 9 United States sites was conducted, representing all patients given palivizumab at each site. Those evaluated were to have a gestational age of < or =35 weeks, were to be <2 years old at their first injection and were to have received at least one dose of palivizumab (humanized monoclonal antibody against RSV) between September, 1998, and May, 1999. Gestational age, comorbidities, frequency of injections, hospitalizations and length of hospital stays were assessed. RESULTS: The antigen- or culture-positive RSV hospitalization rates for those given prophylaxis were 2.3% (42 of 1839) overall, 16/399 (4.0%) with chronic lung disease of infancy and 26 of 1227 (2.1%) born prematurely without chronic lung disease of infancy. Twenty-six patients had a gestational age of >35 weeks and were included in the analysis. CONCLUSIONS: Only 2.3% of children receiving palivizumab prophylaxis were hospitalized with RSV lower respiratory infection. This compares favorably with the rates observed in the pivotal trial (IMpact-RSV trial in 1996 to 1997), in which prophylaxis reduced hospitalization from 10.6% in the placebo group to 4.8% in those children receiving prophylaxis.  相似文献   

17.
Palivizumab prophylaxis significantly reduces hospitalization for respiratory syncytial virus (RSV) disease in preterm infants. However, palivizumab is very expensive. Data from a New Zealand cost-effectiveness analysis were considered by representatives of the Infectious Diseases and Immunisation, Fetus and Newborn, and Respiratory Committees of the Paediatric Society of New Zealand. Prophylaxis in all high-risk groups was associated with net cost. The consensus panel recommends that the priority for palivizumab be given to babies discharged on home oxygen with chronic lung disease, followed by babies born at 28 weeks or less gestation.  相似文献   

18.
A questionnaire study was performed to determine the current status of palivizumab prophylaxis against respiratory syncytial virus infection in Japanese children with congenital heart disease <2 years of age. Palivizumab prophylaxis decreased the respiratory syncytial virus hospitalization rate by 42.8%.  相似文献   

19.
Epidemiological studies performed by the IRIS study group in the last two respiratory syncytial virus (RSV) seasons found that the hospitalization rates for RSV in premature infants born before or in week 32 of gestation were 13.4 % and 13.1 %, respectively. Of these, 18 % and 25 % of the infants were admitted to the intensive care unit. Currently available information demonstrates the efficacy of RSV monoclonal antibodies (palivizumab) and the absence of major adverse effects. To date, there are no data that indicate the need to modify the guidelines for RSV prophylaxis in premature infants published in 2000.  相似文献   

20.
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