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1.
J Perinatol ; 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38844519

ABSTRACT

OBJECTIVES: To determine the appropriate intraosseous (IO) needle insertion site, optimal depth and success using a drill-assisted device (DAD) versus a manually inserted needle (MIN). METHODS: Computed tomography scans of neonatal cadavers were analyzed. Success was based on tibial needle tip placement within the marrow cavity and contrast media distribution. RESULTS: Nineteen cadavers (38 tibiae) were included. The overall success rate was comparable between DAD and MIN needles, but reduced in very-low birthweight (VLBW) infants. The insertion site was consistent across birth weight groups. Contrast leakage occurred overall in 15.8% and 41.7% in VLBW infants and was insignificantly greater in DAD versus MIN needles. Minimum and maximum puncture depth was adjusted for higher BW groups. CONCLUSION: IO needles should be placed 2 cm below and 1-2 cm medial to the tibial tuberosity. MIN needles are preferred to minimize leakage. IO depth should be modified by birth weight.

2.
J Perinatol ; 2024 May 24.
Article in English | MEDLINE | ID: mdl-38789794

ABSTRACT

OBJECTIVES: We prospectively compared cerebral oxygen saturation (CrSO2) and pain score changes during procedures in late preterm (LPT) versus term infants. METHODS: Near-infrared spectroscopy, pulse oximetry, Neonatal Infant Pain Scale (NIPS) and Premature Infant Pain Profile-Revised (PIPP-R) scores were assessed and CrSO2 data analyzed. RESULTS: Thirty infants in each group were evaluated. LPT infants displayed a milder significant drop in Minimum post-procedural CrSO2 and smaller Maximum-Minimum post-procedural CrSO2 disparity. CrSO2 minute changes between the groups were non-significant. Moderate correlations were observed in both groups between NIPS and Minimum post-procedural CrSO2, and a moderate correlation was found in the Maximum-Minimum post-procedural CrSO2 difference in LPT infants. No correlation between PIPP-R and CrSO2 values was noted. CONCLUSION: LPT and term infants demonstrated decreased CrSO2 in response to painful procedures. Correlations between CrSO2 and PIPP-R or NIPS scores were poor to moderate, reflecting the complex nature of these associations relative to gestational age.

5.
Front Public Health ; 11: 1261165, 2023.
Article in English | MEDLINE | ID: mdl-37829087

ABSTRACT

Introduction: Detection of community respiratory syncytial virus (RSV) infections informs the timing of immunoprophylaxis programs and hospital preparedness for surging pediatric volumes. In many jurisdictions, this relies upon RSV clinical test positivity and hospitalization (RSVH) trends, which are lagging indicators. Wastewater-based surveillance (WBS) may be a novel strategy to accurately identify the start of the RSV season and guide immunoprophylaxis administration and hospital preparedness. Methods: We compared citywide wastewater samples and pediatric RSVH in Ottawa and Hamilton between August 1, 2022, and March 5, 2023. 24-h composite wastewater samples were collected daily and 5 days a week at the wastewater treatment facilities in Ottawa and Hamilton, Ontario, Canada, respectively. RSV WBS samples were analyzed in real-time for RSV by RT-qPCR. Results: RSV WBS measurements in both Ottawa and Hamilton showed a lead time of 12 days when comparing the WBS data set to pediatric RSVH data set (Spearman's ρ = 0.90). WBS identify early RSV community transmission and declared the start of the RSV season 36 and 12 days in advance of the provincial RSV season start (October 31) for the city of Ottawa and Hamilton, respectively. The differing RSV start dates in the two cities is likely associated with geographical and regional variation in the incidence of RSV between the cities. Discussion: Quantifying RSV in municipal wastewater forecasted a 12-day lead time of the pediatric RSVH surge and an earlier season start date compared to the provincial start date. These findings suggest an important role for RSV WBS to inform regional health system preparedness, reduce RSV burden, and understand variations in community-related illness as novel RSV vaccines and monoclonal antibodies become available.


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Humans , Child , Palivizumab/therapeutic use , Antiviral Agents/therapeutic use , Ontario/epidemiology , Wastewater-Based Epidemiological Monitoring , Seasons , Cities , Wastewater , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus Infections/drug therapy
6.
Neonatal Netw ; 42(5): 291-302, 2023 Aug 01.
Article in English | MEDLINE | ID: mdl-37657806

ABSTRACT

Respiratory syncytial virus (RSV) is a leading cause of morbidity and hospitalization in young children, and prevention is the primary management strategy. At present, palivizumab, a monoclonal antibody providing immediate passive immunity, rather than a vaccine that induces active immunity, is the only preventive intervention used in routine practice internationally. In Canada, access varies across the country. Prophylaxis policies are mainly driven by cost-effectiveness analyses, and it is crucial that the full costs and benefits of any intervention are captured. Positive results from a new Canadian cost-effectiveness analysis of palivizumab will help address the current inequality in use while providing a framework for future models of RSV preventives. Nurses are the principal educators for parents about the risks of childhood RSV and optimal prevention via basic hygiene, behavioral and environmental measures, and seasonal prophylaxis. Nurses should be provided not only with regular, up-to-date, and accurate information on RSV and the clinical aspects of emerging interventions but be informed on the decision-making governing the use of preventive strategies.

7.
Front Pediatr ; 11: 1238402, 2023.
Article in English | MEDLINE | ID: mdl-37724088

ABSTRACT

Objectives: To explore the level of neonatal care on cumulative phlebotomy loss (cPL) and red cell transfusions in extremely low birthweight [ELBW; birthweight (BW) <1,000 g] infants, up to 40 weeks post-conceptual age (PCA). The secondary objective was to determine the associations between cPL and number of transfusions and between transfusions and hospital outcomes. Methods: A prospective, comparative, observational study was conducted in two level IV and two level III neonatal intensive care units (NICUs) in Thailand. Daily cPL volume and number of blood tests were recorded. Descriptive data are reported as frequency and percentage for categorical variables and median [25th percentile (P25), 75th percentile (P75)] for continuous data according to the data distribution. A p-value <0.05 was considered statistically significant. Results: 210 ELBW infants were included; 99 and 111 were admitted to level IV and level III NICUs, respectively. Birth weight of level IV infants was lower 780.0 [660.0, 875.0] vs. 865.0 [723.0, 930.0] g; p < 0.001]. Initial group hematocrits were similar (43.1% vs. 44.0%, p = 0.47). cPL for each infant was 28.1 [16.5, 46.4] ml. Level IV infants had more tests (n = 89 [54, 195] vs. 59 [37, 88], p < 0.001). Counterintuitively, there was a lower cPL trend in level IV infants, but this was insignificant (19.6 [12.3, 52.3] vs. 28.9 [19.3, 45.3] ml; p = 0.06). The number of transfusions in both NICUs was similar 4 [2, 6], with a strong correlation between cPL and number of transfusions (r = 0.79, p < 0.001). Transfusions were significantly associated with bronchopulmonary dysplasia [BPD; adjusted RR (95% CI): 2.6 (1.2, 5.3), p = 0.01]. Conclusions: Level IV NICUs conducted more blood tests in ELBW infants without a difference in cPL, and number of transfusions. Cumulative PL correlated with number of transfusions and was associated with BPD risk. Minimizing cPL by point-of-care tests and restrictive transfusion criteria, may reduce need for transfusion.

8.
Front Pediatr ; 11: 1243977, 2023.
Article in English | MEDLINE | ID: mdl-37691777

ABSTRACT

Objectives: To determine the correlation and agreement between the SenSmart™ and the INVOS™ devices of neonatal cerebral regional oxygen saturation (CrSO2) measurements using neonatal sensors. The secondary objective was to develop a regression model that predicts CrSO2-INVOS values using CrSO2-SenSmart indices and determine whether the values between the devices are interchangeable. Methods: A prospective, cross-sectional study was conducted in infants during the first 4 weeks of life. Simultaneous, bilateral CrSO2 was measured using the SenSmart™X100 (CrSO2-SenSmart) or INVOS™ 5100C (CrSO2-INVOS) device in each frontoparietal area for 2 h. Five-minute CrSO2 values were extracted for analysis. Results: Thirty infants were recruited with 720 pairwise measurements and 26 (84%) were evaluated in the first week of life. Mean gestational age of the preterm and term infants was [30.9 ± 2.8 (n = 14) and 38.8 ± 1.1 (n = 16)] weeks, respectively. Overall CrSO2- was 77.08 ± 9.70% and 71.45 ± 12.74% for the SenSmart and INVOS, respectively (p < 0.001). The correlation coefficient (r) between the CrSO2-SenSmart and INVOS was 0.20 (p < 0.001). The mean difference between the CrSO2-SenSmart and INVOS was 5.63 ± 13.87% with -21.6% to 32.8% limits of agreement. The r and mean difference was 0.39 (p < 0.001) and 8.87 ± 12.58% in preterm infants, and 0.06 (p = 0.27) and 2.79 ± 14.34 in term infants. Conclusion: The CrSO2-SenSmart tended to read higher than the CrSO2-INVOS device. There was no correlation between the CrSO2-SenSmart and the CrSO2-INVOS in term infants and it was weak in preterms. Due to imprecise agreement, the CrSO2-SenSmart values are not interchangeable with those of the CrSO2-INVOS.

9.
PLoS One ; 18(8): e0289828, 2023.
Article in English | MEDLINE | ID: mdl-37561741

ABSTRACT

Since the last Italian cost-utility assessment of palivizumab in 2009, new data on the burden of respiratory syncytial virus (RSV) and an International Risk Scoring Tool (IRST) have become available. The objective of this study was to provide an up-to-date cost-utility assessment of palivizumab versus no prophylaxis for the prevention of severe RSV infection in otherwise healthy Italian infants born at 29-31 weeks' gestational age (wGA) infants and those 32-35wGA infants categorized as either moderate- or high-risk of RSV-hospitalization (RSVH) by the IRST. A decision tree was constructed in which infants received palivizumab or no prophylaxis and then could experience: i) RSVH; ii) emergency room medically-attended RSV-infection (MARI); or, iii) remain uninfected/non-medically attended. RSVH cases that required intensive care unit admission could die (0.43%). Respiratory morbidity was considered in all surviving infants up to 18 years of age. Hospitalization rates were derived from Italian data combined with efficacy from the IMpact-RSV trial. Palivizumab costs were calculated from vial prices (50mg: €490.37 100mg: €814.34) and Italian birth statistics combined with a growth algorithm. A lifetime horizon and healthcare and societal costs were included. The incremental cost-utility ratio (ICUR) was €14814 per quality-adjusted life year (QALY) gained in the whole population (mean: €15430; probability of ICUR being <€40000: 0.90). The equivalent ICURs were €15139 per QALY gained (€15915; 0.89) for 29-31wGA infants and €14719 per QALY gained (€15230; 0.89) for 32-35wGA infants. The model was most sensitive to rates of long-term sequelae, utility scores, palivizumab cost, and palivizumab efficacy. Palivizumab remained cost-effective in all scenario analyses, including a scenario wherein RSVH infants received palivizumab without a reduction in long-term sequelae and experienced a 6-year duration of respiratory morbidity (ICUR: €27948 per QALY gained). In conclusion, palivizumab remains cost-effective versus no prophylaxis in otherwise healthy Italian preterm infants born 29-35wGA. The IRST can help guide cost-effective use of palivizumab in 32-35wGA infants.


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Infant, Newborn , Infant , Humans , Palivizumab/therapeutic use , Respiratory Syncytial Virus Infections/epidemiology , Cost-Benefit Analysis , Gestational Age , Antiviral Agents/therapeutic use , Infant, Premature , Antibodies, Monoclonal, Humanized/therapeutic use , Risk Factors , Hospitalization , Italy/epidemiology
10.
J Matern Fetal Neonatal Med ; 36(2): 2224491, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37322821

ABSTRACT

OBJECTIVES: To explore whether antenatal dexamethasone impacts postnatal serum cortisol levels in stable late preterm (LPT) infants. Secondary outcomes were to identify short-term hospital outcomes related to antenatal dexamethasone exposure. METHODS: A prospective cohort study of serial serum cortisol levels in LPT infants within 3 h of birth, and at 1, 3, and 14 postnatal days. Serum cortisol levels were compared between infants exposed to antenatal dexamethasone >3 h and <14 days prior to delivery (aDex) and those who either did not receive dexamethasone or were exposed < 3 h or >14 days prior to delivery (no-aDex). RESULTS: Thirty-two LPT infants (aDex) were compared with 29 infants (no-aDEX). Group demographic characteristics were similar. Serum cortisol levels were identical between the groups at all 4-time points. Cumulative antenatal dexamethasone exposure ranged from 0 to 12 doses. Post-hoc analysis of the 24-hour serum cortisol levels indicated a significant difference between 1 to 3 cumulative doses versus 4 or more doses (p = .01). Only 1 infant in the aDex group had a cortisol level <3rd percentile of the reference value. Rates of hypoglycemia (absolute difference [95% CI] - 1.0 [-16.0,15.0]; p = .90) and mechanical ventilation were similar in both groups (absolute difference [95%CI] - 0.3 [-9.3,8.7]; p = .94). No deaths occurred. CONCLUSION: Antenatal dexamethasone administered 14 days prior to delivery did not affect serum cortisol levels and short-term hospital outcomes in stable LPT infants. Exposure to low cumulative doses of dexamethasone resulted in transient low serum cortisol levels compared to 4 or more doses only at 24-hours.


Subject(s)
Hydrocortisone , Infant, Premature , Infant , Infant, Newborn , Female , Humans , Pregnancy , Dexamethasone , Prospective Studies , Glucocorticoids
11.
J Med Econ ; 26(1): 630-643, 2023.
Article in English | MEDLINE | ID: mdl-37067826

ABSTRACT

BACKGROUND AND OBJECTIVE: To assess the cost-utility of palivizumab versus no prophylaxis in preventing severe respiratory syncytial virus (RSV) infection in Canadian moderate-to-late preterm (32-35 weeks' gestational age) infants using an (i) International Risk Scoring Tool (IRST) and (ii) Canadian RST (CRST). METHODS: A decision tree was developed to assess cost-utility. Infants assessed at moderate- and high-risk of RSV-related hospitalization (RSVH) by the IRST or CRST received palivizumab or no prophylaxis and then progressed to either (i) RSVH; (ii) emergency room/outpatient medically attended RSV-infection (MARI) or (iii) were uninfected/non-medically attended. Infants admitted to intensive care could incur mortality (0.43%). Respiratory morbidity was accounted in all uninfected surviving infants for 6 years or 18 years (RSVH/MARI). Palivizumab efficacy (72.2% RSVH reduction) and hospital outcomes were from the Canadian CARESS, PICNIC and RSV-Quebec studies. Palivizumab costs (50 mg: CAN$752; 100 mg: $1,505) were calculated from Canadian birth statistics combined with a growth algorithm. Healthcare/payer and societal costs (May 2022; 1.5% discounting) were included. RESULTS: Cost per quality-adjusted life year (QALY) was $29,789 with the IRST (0.79 probability of being <$50,000) and $15,833 with the CRST (0.96 probability). The model was most sensitive to utility scores, long-term sequelae and palivizumab cost. Vial sharing improved the incremental cost-utility ratio (IRST: $22,319; CRST: $9,231). CONCLUSIONS: Palivizumab was highly cost-effective (vs no prophylaxis) in Canadian moderate-to-late preterm infants using either the IRST or CRST. The IRST has fewer risk factors than the CRST (3 vs 7, respectively), captures more potential RSVHs (85% vs 54%) and provides another option to guide cost-effective RSV prophylaxis in Canada.


Subject(s)
Respiratory Syncytial Virus Infections , Infant , Infant, Newborn , Humans , Palivizumab/therapeutic use , Respiratory Syncytial Virus Infections/prevention & control , Antiviral Agents/therapeutic use , Infant, Premature , Canada , Risk Factors , Hospitalization
14.
Front Public Health ; 11: 1316531, 2023.
Article in English | MEDLINE | ID: mdl-38283294

ABSTRACT

Respiratory syncytial virus (RSV) is the leading viral cause of childhood bronchiolitis and pneumonia causing over 3 million hospitalizations and 100,000 deaths in children under 5 years of age annually. Wastewater-based surveillance (WBS) has proven an effective early warning system for high-consequence pathogens, including SARS-CoV-2, polio, mpox, and influenza, but has yet to be fully leveraged for RSV surveillance. A model predicated on the Canadian province of Ontario demonstrates that implementation of a WBS system can potentially result in significant cost savings and clinical benefits when guiding an RSV preventive program with a long-acting monoclonal antibody. A network of integrated WBS initiatives offers the opportunity to help minimize the devastating global burden of RSV in children by optimizing the timing of preventive measures and we strongly advocate that its benefits continue to be explored.


Subject(s)
Respiratory Syncytial Virus Infections , Humans , Child , Child, Preschool , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus Infections/epidemiology , Wastewater-Based Epidemiological Monitoring , Respiratory Syncytial Viruses , Antibodies, Monoclonal , Ontario/epidemiology
15.
Case Rep Genet ; 2022: 4791082, 2022.
Article in English | MEDLINE | ID: mdl-36212619

ABSTRACT

Pfeiffer syndrome (PS) is an autosomal dominant disorder with three subtypes stemming from heterozygous mutations in the fibroblast growth factors FGFR1 and FGFR2. The subtypes overlap with heterogeneous clinical manifestations and variable prognosis dependent on neurological and respiratory compromise that impact short- and long-term outcomes and survival. We present a male, term infant with type II PS that was diagnostically suspected antenatally based on three-dimensional ultrasonographic findings that were confirmed postnatally by craniofacial tomography and magnetic resonance imaging. A new generation sequencing panel identified a unique de novo FGFR2, c.335 A > G p. Tyr112Cys variant, the first of its kind, and features that closely aligned with subtype II PS. Initial molecular results categorized the mutation as nonpathogenic, but it was later reclassified as pathogenic. Antenatal, multidisciplinary parental counseling about the tentative diagnosis and prognosis facilitated postnatal decisions that culminated in an informed choice for palliative care and early demise.

16.
Risk Manag Healthc Policy ; 15: 1809-1821, 2022.
Article in English | MEDLINE | ID: mdl-36171869

ABSTRACT

Background: The incidence of tracheostomy insertion in pediatric patients has increased over the last few decades. Tracheostomized pediatric patients need daily, meticulous care by qualified nurses to minimize severe, avoidable complications. Adequately trained nurses facilitate patients' stability, accelerate weaning from the ventilator, and reduce potential tracheostomy dislodgement. Methods: A cross-sectional, retrospective cohort survey was conducted in September 2021, using an electronic version of a self-questionnaire, to assess nurses' knowledge and comfort level regarding tracheostomy care of pediatric patients at the International Extended Care Center in Jeddah, Saudi Arabia. Statistical analysis of the accrued data was performed using the SPSS 21.0 software package and a P-value <0.05 calculated by t-Test, was considered significant. Results: Among 43 nurses included in the study, 14 (32.6%) were very comfortable taking care of tracheostomized patients, 13 (30.2%) were comfortable, and 16 (37.2%) were uncomfortable. Regarding knowledge, three main aspects of tracheostomy care were correctly answered (%) by all the nurses: knowledge of routine tracheal care (55%), tracheal care skills (11.6%), and tracheal emergency care (2.3%). The study showed a significant positive correlation between nurses' comfort level with tracheal care and academic degree, duration of pediatric experience, completion of more than one life support course, and attendance at the annual local tracheostomy care competency learning program (TCCLP; all P <0.05). Conclusion: Deficits exist in nurses' knowledge of tracheostomy care. Improved knowledge garnered through repetitive participation in tracheostomy competency programs and life support courses correlate with greater comfort and more than 5 years of pediatric experience. Nurses' deficits in emergency care knowledge and skills should be addressed through a structured educational program and a simulation, hands-on based TCCLP course, irrespective of comfort level with tracheostomy care.

17.
Blood Coagul Fibrinolysis ; 33(4): 193-200, 2022 Jun 01.
Article in English | MEDLINE | ID: mdl-35285449

ABSTRACT

Among children, neonates have the highest incidence of thrombosis. Thrombolytic agents are used for the management of life and/or organ-threatening thrombosis. Literature on the efficacy and safety of thrombolytic agents in neonates is limited. We reviewed the evidence on dosing, administration, monitoring and treatment duration of tissue plasminogen activator (tPA), streptokinase and urokinase (URK) in neonates (≤ 28days). A systematic literature search was conducted of current databases from inception until 31 March 2021. The initial search yielded 6881 articles and 18 were retained for review. tPA, streptokinase and URK was utilized in 12, seven and four studies on 115, 51 and 16 patients, respectively. The dose range for tPA, streptokinase and URK was 0.01 -0.6 mg/kg/h, 50-2000 and 1000-0 000 units/kg/h, respectively, and treatment duration ranged from 30 min to 30 days. This is the first study to objectively summarize the efficacy and safety of thrombolytic agents in neonates. Overall, thrombolysis was associated with 87.9% complete or partial thrombus resolution and 7.4% recurrence risk. The bleeding risk associated with thrombolytic agents was 23.1% on pooled analysis, which is higher than other anticoagulants. Larger prospective studies are required to determine effective dosing regimens of these therapeutic drugs and further clarify their efficacy and safety. Blood Coagul Fibrinolysis 33:000-000 Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.


Subject(s)
Fibrinolytic Agents , Thrombosis , Child , Fibrinolytic Agents/therapeutic use , Humans , Infant, Newborn , Streptokinase/therapeutic use , Thrombolytic Therapy , Thrombosis/drug therapy , Tissue Plasminogen Activator/therapeutic use , Urokinase-Type Plasminogen Activator
18.
Pediatr Blood Cancer ; 69(6): e29668, 2022 06.
Article in English | MEDLINE | ID: mdl-35289485

ABSTRACT

Among children, neonates have the highest incidence of thrombosis. We conducted a retrospective review of neonatal thrombosis, in a single intensive care unit (ICU) over 4.5 years. Among 4860 ICU admissions to our center, identified through the Canadian Neonatal Network database, 186 were associated with arterial and venous thrombosis involving 195 thrombotic sites. The neonatal thrombosis incidence was 38 per 1000 neonatal ICU admissions. We assessed patient characteristics and compared the association between risk factors and thrombosis. In the multivariate analysis, central venous catheters, sepsis, and respiratory distress syndrome were significant predictors of neonatal thrombosis.


Subject(s)
Catheterization, Central Venous , Thrombosis , Canada/epidemiology , Catheterization, Central Venous/adverse effects , Child , Humans , Infant, Newborn , Intensive Care Units, Neonatal , Retrospective Studies , Risk Factors , Thrombosis/epidemiology , Thrombosis/etiology
19.
Blood Coagul Fibrinolysis ; 33(2): 83-89, 2022 Mar 01.
Article in English | MEDLINE | ID: mdl-35001043

ABSTRACT

The incidence of neonatal venous and arterial thrombosis ranges from 6.9 to 15/1000 neonatal ICU (NICU) admissions, and is likely an underestimate based on population demographics, frequency of surveillance and vascular catheterization. This retrospective study involving 234 infants reviewed the epidemiology, diagnosis, and management of neonatal thrombosis in a single, tertiary care institution over more than 10 years. The incidence of thrombosis was 25/1000 NICU admissions, with a preterm to term infant ratio of 1.5 : 1 and a slightly higher proportion of male sex (55.1%). The mean (range) gestational age and birth weight was 33.8 weeks (23-41.6) and 2360 g (512-5890). The median age (IQR) of thrombus diagnosis was 7 (3-17) days. Portal vein thrombosis was most prevalent (59.4%) compared with other sites of thrombosis. Almost three-quarter (171/234; 73.1%) of the thrombotic episodes were line-related, while infection and surgery were associated with 19.7% (46/234) and 10.7% (25/234), respectively. Twenty patients (8.3%) were screened for thrombophilia and 3 were positive; 2 for antithrombin deficiency, 1 for factor V Leiden gene mutation. Subjects were followed with imaging for 3 months with a treatment duration, mean (IQR) of 33.5 (10.8-42.5) days. Complete clot resolution was significantly higher in the anticoagulation group (48%; 17%; P = 0.03) compared with untreated patients. No group difference was noted for partial thrombus resolution (33.3%; 12.4%; P = 0.313). Anticoagulation halted thrombus progression (2.6 versus 12.4%; P = 0.025) and fewer treated patients failed to attend follow-up visits (6.5 versus 18.6%; P = 0.022). Well designed, multicenter prospective studies with larger sample sizes are required to confirm these findings.


Subject(s)
Thrombosis , Venous Thrombosis , Cohort Studies , Humans , Infant , Infant, Newborn , Male , Prospective Studies , Retrospective Studies , Thrombosis/diagnosis , Thrombosis/drug therapy , Thrombosis/epidemiology
20.
Am J Perinatol ; 39(15): 1668-1677, 2022 11.
Article in English | MEDLINE | ID: mdl-33657636

ABSTRACT

OBJECTIVE: This study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH). STUDY DESIGN: It involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection. RESULTS: A total of 25,003 infants (56.3% male) were enrolled at 32 sites; 109,579 PVZ injections were administered. Indications included: prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%). The "miscellaneous" group increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017) and included: trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group. Adherence measured by expected versus actual doses plus correct interdose interval was 64.7%. A total of 2,054 RIH occurred (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH 1.6%). Risk factors for RSVH included having siblings, attending daycare, family history of atopy, smoking exposure, and crowded household. Infants with 5 risk factors were 9.0 times (95% CI or confidence interval 4.4-18.2; p < 0.0005) more likely to have RSVH than infants without risk factors. Three adverse events occurred; none were fatal. CONCLUSION: Results are relevant to both clinicians and decision-makers. We confirmed the safety of PVZ. Use of PVZ increased steadily for children with miscellaneous conditions and medical complexity. Medical and social factors pose a risk for severe RIH and RSVH with accompanying burden of illness. A vaccine that protects against RSV is urgently required. KEY POINTS: · Main indications were prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%).. · The proportion of children in the "miscellaneous" group, comprised of those with trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group, increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017).. · Respiratory illness-related hospitalization occurred in 2,054 children (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH: 1.6%)..


Subject(s)
Bronchopulmonary Dysplasia , Cystic Fibrosis , Down Syndrome , Heart Defects, Congenital , Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Infant , Infant, Newborn , Child , Male , Humans , Female , Palivizumab/therapeutic use , Prospective Studies , Cystic Fibrosis/complications , Cystic Fibrosis/drug therapy , Bronchopulmonary Dysplasia/complications , Down Syndrome/complications , Antiviral Agents/therapeutic use , Canada/epidemiology , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus Infections/drug therapy , Hospitalization , Disease Progression
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