An update of the recommendations of the spanish neonatology society for the use of paivizumab as prophylaxis for severe infections due to syncytial respiratory virus in high risk infants (original) (raw)
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Journal of Paediatrics and Child Health, 2003
In 1998 the Food and Drug Administration approved palivizumab (Synagis) for the prevention of severe lower respiratory tract infection secondary to respiratory syncytial virus (RSV) in pediatric patients at high risk for developing disease that required hospitalization. In the immediate aftermath of that approval, two retrospective reviews were conducted on 4669 medical records of patients who received at least 1 dose of palivizumab during the 1998 to 1999 and 1999 to 2000 RSV seasons, respectively. These analyses captured data on rates of RSV hospitalization, length of hospital stay, intensive care unit admission and compliance with palivizumab administration. Two prospective US multicenter registry trials followed, during the RSV seasons of 2000 to 2001 and 2001 to 2002. The registries characterized the demographics and outcomes of a total of 7207 high risk infants and children who received prophylaxis for RSV, the risk factors for RSV hospitalization and the patterns and scope of palivizumab usage across 63 and 116 US health care sites, respectively. 1998 to 1999 palivizumab first season of general use. Nine US study sites engaged in a retrospective chart review of infants and children with a gestational age of <35 weeks and a chronologic age of <2 years at the time of their first palivizumab injection and who had received at least one dose between September 1998 and May 1999. Of the 1839 prophylaxed children with evaluable data, only 42 (2.3%) were hospitalized with confirmed RSV disease. Of those admitted with confirmed gestational ages, all were premature; the majority were either <28 weeks gestational age (WGA; 43%) or between 28 and 32 WGA (34%). 1999 to 2000 palivizumab second season of general use. During the 1999 to 2000 RSV season, 12 hospitals and university medical centers, representing a cross-section of US health care facilities, contributed to the second Palivizumab Study Group. The sites collected retrospective data from the charts of 2830 children, all of whom had received at least 1 injection of palivizumab between September 1999 and May 2000. Analysis of 2830 medical records revealed an admission rate of 2.4% (68 of 2830) for confirmed RSV infection, consistent with the overall hospitalization rate of 2.3% from the previous season. Palivizumab Outcomes Registry: 2000 to 2001. Sixty-three sites representing pediatric offices, freestanding clinics and hospital-based clinics participated in a prospective, multicenter, observational study to evaluate the scope of palivizumab usage in a cross-section of US infants. The centers collected outcomes data on RSV-related hospital admissions, injection history and adherence to a standardized palivizumab administration protocol. Of the 2116 infants enrolled 47% were born at <32 weeks gestation. Patients between 32 and 35 weeks gestational age accounted for another 45% of enrollees. Approximately 8% had a gestational age of >35 weeks. For the 2049 subjects with available follow-up data, the overall confirmed RSV hospitalization rate was 2.9%.
Archives of Disease in Childhood - Fetal and Neonatal Edition, 2005
Objectives: To determine the rates of hospital admission for respiratory syncytial virus (RSV) infection among children born at different gestational ages. To assess the theoretical impact of palivizumab prophylaxis on admissions for RSV infection. Design: Retrospective cohort study of children born in 1991-2000. Setting: Tertiary care university hospital. Methods: Data on all children born during the 10 year period were combined with information on laboratory confirmed RSV infections in these children until the end of 2002. The theoretical impact of palivizumab on RSV associated admissions was estimated by applying the current recommendations for prophylaxis to the study population and using the observed rates of admission in the calculations. Interventions: None. Main outcome measures: Rates of RSV infection and hospital admission in different subgroups of children.
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2012
We examined the dosing regimens, compliance, and outcomes of premature infants who received palivizumab within the Canadian Registry of Palivizumab (CARESS). Infants receiving ≥1 dose of palivizumab during the 2006–2011 respiratory syncytial virus (RSV) seasons were recruited across 30 sites. Respiratory illness events were captured monthly. Infants ≤32 completed weeks gestational age (GA) (Group 1) were compared to 33–35 completed weeks GA infants (Group 2) following prophylaxis. In total, 6,654 patients were analyzed (Group 1, n = 5,183; Group 2, n = 1,471). The mean GA was 29.9 ± 2.9 versus 34.2 ± 2.2 weeks for Groups 1 and 2, respectively. Group differences were significant (all p-values <0.05) for the following: proportion of males, Caucasians, siblings, multiple births, maternal smoking, smoking during pregnancy, household smokers, >5 household individuals, birth weight, and enrolment age. Overall, infants received 92.6 % of expected injections. Group 1 received significantly more injections, but a greater proportion of Group 2 received injections within recommended intervals. The hospitalization rates were similar for Groups 1 and 2 for respiratory illness (4.7 % vs. 3.7 %, p = 0.1) and RSV (1.5 % vs. 1.4 %, p = 0.3). Neither the time to first respiratory illness [hazard ratio = 0.9, 95 % confidence interval (CI) 0.7–1.2, p = 0.5] nor to first RSV hospitalization (hazard ratio = 1.3, 95 % CI 0.8–2.2, p = 0.3) were different. Compliance with RSV prophylaxis is high. Despite the higher number of palivizumab doses in infants ≤32 completed weeks GA, the two groups’ respiratory illness and RSV-positive hospitalization rates were similar.
Respiratory syncytial virus (RSV) is the major cause of bronchiolitis and viral pneumonia in children younger than 1 yr of age. Infection with respiratory syncytial virus (RSV) is one of the major causes of childhood respiratory morbidity and hospitalization. Palivizumab, a humanized monoclonal antibody, has been recommended for high risk infants to prevent severe RSV-associated respiratory illness. Key ward:palvizumab +bronchiolitis+RSV A randomized clinical trial was done in Karballa Teaching Hospital For Pediatrics from October 2015-march 2017 to studies the protective effect of palivizumab prophylaxis for reducing RSV-associated hospitalizations in infants with congenital heart disease and premature infants. We studied 84 patients divided to 2 groups(group A&B) : 30 patients with congenital heart disease their age less than 1 year considered group A and 54 premature neonates who are delivered at the season of RSV(October –March) considered group B . Group A(30 patients) :subdivided to 2 subgroups: A1&A2,both had hemodynamically significant CHD(large VSD &PDA,complete AV canal with heart failure and on medical treatment,TOF and D-TGA ) . 18 patients who received 5 doses of palvizumab monthly(from October- March) considered as group A1and 12 patients who received 3 doses monthly considered as group A2,with monthly follow up for signs of any respiratory illness. Group B (54patients): subdivided to 2 subgroups:B1&B2 both were premature neonates their gestational age less than 35 weeks of gestation and their body weight less than 1500gm .25 patients they were received 5 doses of palvizumab monthly for 5 months from October-March considerd as group B1 and 25 patients they were received 3 doses of palvizumab monthly considered as groupB2. 2patients received 2 doses only and developed irritability &cough therefore we stopped palvizumab injection,2 patients received one dose and escape from follow up(therefore those 4 patients were excluded from the study). premature neonates with severe sepsis,severe jaundice,severe congenital malformation,history of birth asphyxia and complex congenital heart disease also were excluded from the study All 4 groups were received palvizumab 15mg/kg intramuscular monthly with regular follow up each months for any sign of respiratory distress. For each group we select control groupC1(30 patients with CHD)&group C2(50 premature infants) :they didn’t received palvizumab ,both groups were taken from cardiology clinic,outpatients clinic &premature department &compared with each group. The results for group A1, 3 patients developed mild bronchiolitis without hospitalization,for group A2 only one patient(8.33%) need hospitalization . The results for group B1, 7 of them they developed mild bronchiolitis and they didn’t need hospitalization,for groupB2, 8 of them they developed mild bronchiolitis and one of them(4%) need hospitalization for 2 weeks.no death was reported. Regarding control group: 30 patients with CHD(group C1) who didn’t received palvizumab,21(70%) patients they were need hospitalization &1 death was reported . and from 50 patients premature infants(group C2) ,39 patients(78%) developed bronchiolitis and they need admittion &4 death was reported. In this study we found breast feeding had significant factor that contribute to the reduction of severity of bronchiolitis and rate of hospitalization. From this study we recommend :the usage of palvizumab as prophylaxis against RSV for premature infants & hemodynamically significant CHD because its effectiveness in reduction of morbidity &mortality. And encourage breast feeding for its effectiveness against severe disease in infants below 1 year.
Journal of Hospital Infection, 2004
To evaluate the safety and effectiveness of a humanized respiratory syncytial virus (RSV) monoclonal antibody (palivizumab) to control an outbreak of RSV in a neonatal intensive care unit (NICU), we retrospectively analysed two RSV outbreaks. Between 11 November 1998 and 18 March 1999, two separate RSV outbreaks occurred in a large (26 beds) NICU. All procedures for preventing nosocomial spread of RSV (including the use of palivizumab in the second outbreak) were retrospectively analysed. The cumulative incidence (CI), secondary attack rate (SAR) and risk ratio of infection were determined before and after the use of palivizumab for all patients and for those with gestational age below and above 32 weeks in the NICU during the second outbreak. Standard infection control measures were effective in the first outbreak (three cases). In the second outbreak, after three index cases, five additional infants were newly RSV-infected within one month. Three infants had RSV pneumonia and required mechanical ventilation; one infant died. Standard infection control procedures were initiated from the beginning of this outbreak. Palivizumab was given to all infants in the NICU after the fifth case was identified. CI was 2.4% in the first 15 days and 10.5% in the second, and SAR was 2.9‰ in the first 15 days and 14.1‰ in the second, both dropping to zero after the administration of palivizumab. The risk ratio of infection was 4.65 times higher in infants under 32 weeks gestational age. After the use of palivizumab, there were no additional identified cases. In addition to careful infection control procedures, the use of palivizumab might have contributed to arresting the outbreak of RSV infection in the NICU, suggesting that it could be an additional resource in the control of severe nosocomial RSV outbreaks.
Palivizumab reimbursement criteria and neonatal RSV hospitalisation: a regional retrospective review
BMJ Paediatrics Open, 2021
In Italy, reimbursement restrictions regarding palivizumab prophylaxis approved in 2016 have been revoked in 2017, restoring use in infants with Gestational Age (GA) >29 weeks. Respiratory Syncytial Virus (RSV) hospitalisations and prevalence of palivizumab use in infants aged <6 months during five seasons (2014-2019), were considered according to different GA. Although RSV hospitalisations rate showed no significant changes, during different seasons in all GA, lower prevalence of palivizumab use in 2016 (0.8% vs 0.3%), returned to a higher level following the revoke of restrictions. Changes in reimbursement criteria were not associated with neonatal RSV hospitalisations rate but with a significant impact on palivizumab use.
Biologics Targets Therapy, 2007
Respiratory syncytial virus (RSV) is a leading cause of hospitalization in children less than 1 year of age and causes substantial morbidity. Although there is not currently a vaccine available to prevent RSV infection, prophylaxis with the humanized monoclonal antibody palivizumab has been shown to reduce the rate of RSV hospitalization in premature infants and those infants with chronic lung disease or congenital heart disease. Because palivizumab has not been shown to have a beneficial clinical effect on established RSV disease such as reducing the rate of mechanical ventilation and mortality in children afflicted with RSV, there has been considerable debate as to the cost-benefit ratio of administering palivizumab according to international guidelines. Palivizumab has demonstrated a favorable side-effect profile in clinical trials without the development of anti-palivizumab antibodies. Future studies are needed to determine whether palivizumab, or other more potent monoclonal antibodies which are currently undergoing clinical trials, will reduce the long-term sequelae of RSV infection such as the development of wheezing and asthma.