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1.
Semin Perinatol ; 47(5): 151783, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37380528

RESUMO

We present a systematic scoping review of the literature, which documents that only a very small number of interventions related to delivery room stabilization and resuscitation have been studied for their economic impact. Published analyses are mostly of programmatic interventions such as resuscitation training programs, are mostly in low-resource settings, and are of variable methodological quality. Investigators who are conducting clinical studies of delivery room interventions can address these deficiencies in the literature by engaging with health services researchers to assess economic outcomes alongside those studies. We provide a framework of five questions that clinical researchers may use to decide on when such an ancillary study is indicated, and to provide them with the necessary language to discuss the methodological details of potential evaluations with their health services colleagues. Emphasis should be given to interventions that are targeted to high volumes of patients, are expensive, or are likely to lead to changes in costly chronic outcomes.


Assuntos
Análise Custo-Benefício , Ressuscitação , Humanos , Recém-Nascido , Ressuscitação/economia
2.
J Med Econ ; 25(1): 1255-1266, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36377363

RESUMO

OBJECTIVES: Preterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment. METHODS: The ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p < .05). RESULTS: The model predicted improvements for all outcomes. RP-CM decreased neonatal and maternal hospital stay by 19% (p = .029) and 8.5% (p = .001), respectively; neonatal costs' point estimate by 16% (p = .098); and moderate-to-severe neonatal morbidity/mortality by 29% (p = .025). RP-MM strengthened observed reductions and significance. Point estimates of benefit did not differ by race/ethnicity. CONCLUSIONS: Modeled evaluation of a biomarker-based test-and-treat strategy in a diverse population predicts clinically and economically meaningful improvements in neonatal and maternal outcomes.


Preterm birth, defined as delivery before 37 weeks' gestation, is the leading cause of illness and death in newborns. In the United States, more than 10% of infants are born prematurely, and this rate is substantially higher in lower-income, inner-city and Black populations. Prematurity associates with greatly increased risk of short- and long-term medical complications and can generate significant costs throughout the lives of affected children. Annual U.S. health care costs to manage short- and long-term prematurity complications are estimated to exceed $25 billion.Clinical interventions, including case management (increased patient outreach, education and specialist care), pharmacological treatment and their combination can provide benefit to pregnancies at higher risk for preterm birth. Early and sensitive risk detection, however, remains a challenge.We have developed and validated a proteomic biomarker risk predictor for early identification of pregnancies at increased risk of preterm birth. The ACCORDANT study modeled treatments with real-world patient data from a racially and ethnically diverse U.S. population to compare the benefits of risk predictor testing plus clinical intervention for higher-risk pregnancies versus no testing and standard care. Measured outcomes included neonatal and maternal length of hospital stay, associated costs and neonatal morbidity and mortality. The model projected improved outcomes and reduced costs across all subjects, including ethnic and racial minority populations, when predicted higher-risk pregnancies were treated using case management with or without pharmacological treatment. The biomarker risk predictor shows high potential to be a clinically important component of risk stratification for pregnant women, leading to tangible gains in reducing the impact of preterm birth.


Assuntos
Nascimento Prematuro , Gravidez , Feminino , Recém-Nascido , Humanos , Nascimento Prematuro/prevenção & controle , Análise Custo-Benefício , Proteômica , Idade Gestacional , Biomarcadores
3.
J Pediatr ; 245: 72-80.e6, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35304168

RESUMO

OBJECTIVE: To describe the trend in costs over 10 years for tertiary-level neonatal care of infants born 220/7-286/7 weeks of gestation during an ongoing Canadian national quality improvement project. STUDY DESIGN: Clinical characteristics, outcomes, and third-party payor costs for the tertiary neonatal care of infants born 220/7-286/7 weeks of gestation between the years 2010 and 2019 were analyzed from the Canadian Neonatal Network database. Costs were estimated using resource use data from the Canadian Neonatal Network and cost inputs from hospitals, physician billing, and administrative databases in Ontario, Canada. Cost estimates were adjusted to 2017 Canadian dollars (CAD). A generalized linear mixed-effects model with gamma regression was used to estimate trends in costs. RESULTS: Between 2010 and 2019, the number of infants born <24 weeks of gestation increased from 4.4% to 7.7%. The average length of stay increased from 68 days to 75 days. Unadjusted average ± SD total costs per neonate were $120 717 ± $93 062 CAD in 2010 and $132 774 ± $93 161 CAD in 2019. After adjustment for year, center, and gestation, total costs and length of stay increased significantly, by $13 612 CAD (P < .01) and 8.1 days (P < .01) over 10 years, respectively; whereas costs accounting for LOS remained stable. CONCLUSIONS: The total costs and length of stay for infants 220/7-286/7 weeks of gestation have increased over the past decade in Canada during an ongoing national quality improvement initiative; however, there was an increase in the number and survival of neonates at the age of periviability.


Assuntos
Doenças do Prematuro , Terapia Intensiva Neonatal , Canadá , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal , Ontário , Gravidez , Estudos Retrospectivos
4.
BMC Pediatr ; 22(1): 27, 2022 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-34996401

RESUMO

BACKGROUND: Black very low birth weight (VLBW; < 1500 g birth weight) and very preterm (VP, < 32 weeks gestational age, inclusive of extremely preterm, < 28 weeks gestational age) infants are significantly less likely than other VLBW and VP infants to receive mother's own milk (MOM) through to discharge from the neonatal intensive care unit (NICU). The costs associated with adhering to pumping maternal breast milk are borne by mothers and contribute to this disparity. This randomized controlled trial tests the effectiveness and cost-effectiveness of an intervention to offset maternal costs associated with pumping. METHODS: This randomized control trial will enroll 284 mothers and their VP infants to test an intervention (NICU acquires MOM) developed to facilitate maternal adherence to breast pump use by offsetting maternal costs that serve as barriers to sustaining MOM feedings and the receipt of MOM at NICU discharge. Compared to current standard of care (mother provides MOM), the intervention bundle includes three components: a) free hospital-grade electric breast pump, b) pickup of MOM, and c) payment for opportunity costs. The primary outcome is infant receipt of MOM at the time of NICU discharge, and secondary outcomes include infant receipt of any MOM during the NICU hospitalization, duration of MOM feedings (days), and cumulative dose of MOM feedings (total mL/kg of MOM) received by the infant during the NICU hospitalization; maternal duration of MOM pumping (days) and volume of MOM pumped (mLs); and total cost of NICU care. Additionally, we will compare the cost of the NICU acquiring MOM versus NICU acquiring donor human milk if MOM is not available and the cost-effectiveness of the intervention (NICU acquires MOM) versus standard of care (mother provides MOM). DISCUSSION: This trial will determine the effectiveness of an economic intervention that transfers the costs of feeding VLBWand VP infants from mothers to the NICU to address the disparity in the receipt of MOM feedings at NICU discharge by Black infants. The cost-effectiveness analysis will provide data that inform the adoption and scalability of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04540575 , registered September 7, 2020.


Assuntos
Leite Humano , Mães , Aleitamento Materno/métodos , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Semin Perinatol ; 46(2): 151547, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34887108

RESUMO

Neonatal intensive care for infants born at 22-24 weeks has become more prevalent in the past three decades, but outcomes remain highly variable between centers, in part due to different approaches in management. With this increased frequency of intervention, there has been concern for a concurrent increase in costs of care for survivors. This article reviews the direct medical, direct non-medical, and indirect costs of care for periviable infants and their families, as well as the current limitations of published data. In addition, we highlight the cost-effectiveness of neonatal intensive care and various therapies offered to extremely preterm infants, while also considering the ethical dilemmas inherently tied to periviable decision-making. Strategies to improve the gaps in knowledge on the economic impact of the smallest infants are discussed.


Assuntos
Lactente Extremamente Prematuro , Terapia Intensiva Neonatal , Análise Custo-Benefício , Idade Gestacional , Humanos , Lactente , Recém-Nascido
6.
Clinicoecon Outcomes Res ; 13: 809-820, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548799

RESUMO

BACKGROUND: Preterm birth (PTB) carries increased risk of short- and long-term health problems as well as higher healthcare costs. Current strategies using clinically accepted maternal risk factors (prior PTB, short cervix) can only identify a minority of singleton PTBs. OBJECTIVE: We modeled the cost-effectiveness of a risk-screening-and-treat strategy versus usual care for commercially insured pregnant US women without clinically accepted PTB risk factors. The risk-screening-and-treat strategy included use of a novel PTB prognostic blood test (PreTRM®) in the 19th-20th week of pregnancy, followed by treatment with a combined regimen of multi-component high-intensity-case-management and pharmacologic interventions for the remainder of the pregnancy for women assessed as higher-risk by the test, and usual care in women without higher risk. METHODS: We built a cost-effectiveness model using a combined decision-tree/Markov approach and a US payer perspective. We modeled 1-week cycles of pregnancy from week 19 to birth (preterm or term) and assessed costs throughout the pregnancy, and further to 12-months post-delivery in mothers and 30-months in infants. PTB rates and costs were based on >40,000 mothers and infants from the HealthCore Integrated Research Database® with birth events in 2016. Estimates of test performance, treatment effectiveness, and other model inputs were derived from published literature. RESULTS: In the base case, the risk-screening-and-treat strategy dominated usual care with an estimated 870 fewer PTBs (20% reduction) and $54 million less in total cost ($863 net savings per pregnant woman). Reductions were projected for neonatal intensive care admissions (10%), overall length-of-stay (7%), and births <32 weeks (33%). Treatment effectiveness had the strongest influence on cost-effectiveness estimates. The risk-screening-and-treat strategy remained dominant in the majority of probabilistic sensitivity analysis simulations and model scenarios. CONCLUSION: Use of a novel prognostic test during pregnancy to identify women at risk of PTB combined with evidence-based treatment is estimated to reduce total costs while preventing PTBs and their consequences.

7.
Semin Perinatol ; 45(3): 151391, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33583609

RESUMO

Economic evaluations performed alongside randomized controlled trials benefit from the protections against bias inherent in randomization. In this systematic review, we assessed the frequency and quality of economic assessments alongside randomized controlled trials of interventions in neonates published between 1990 and 2016. Over that period, 58 economic assessments were published, corresponding to approximately 2% of RCTs. We noted significant methodological limitations of these studies, including limitation of included costs to the health sector or payer rather than broader categories such as family or community expenditures (81%), short time horizon for cost measurement (less than one year in 60%), lack of reporting of uncertainty (26%), and infrequent analysis of costs and effects in a single metric (combined in 45%). Strategies for improving the quality and frequency of economic evaluations in neonatology are discussed, including selection of appropriate trials, funding, and peer review.


Assuntos
Neonatologia , Análise Custo-Benefício , Humanos , Recém-Nascido , Ensaios Clínicos Controlados Aleatórios como Assunto , Incerteza
8.
Semin Perinatol ; 45(3): 151394, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33581862

RESUMO

While the high costs of neonatal intensive care have been a topic of increasing study, the financial impact on families have been less frequently reported or summarized. We conducted a systematic review of the literature using Pubmed/Medline and EMBASE (1990-2020) for studies reporting estimates of out-of-pocket costs or qualitative estimates of financial burden on families during a neonatal intensive care unit stay or after discharge. 44 studies met inclusion criteria, with 25 studies providing cost estimates. Cost estimates primarily focused on direct non-medical out-of-pocket costs or loss of productivity, and there was a paucity of cost estimates for insurance cost-sharing. Available estimates suggest these costs are significant to families, cause significant stress, and may impact care received by patients. More high-quality studies estimating the entirety of out-of-pocket costs are needed, and particular attention should be paid to how these costs directly impact the care of our high-risk population.


Assuntos
Efeitos Psicossociais da Doença , Terapia Intensiva Neonatal , Gastos em Saúde , Humanos , Lactente , Recém-Nascido , Fatores de Risco
10.
J Pediatr ; 231: 74-80, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33338495

RESUMO

OBJECTIVE: To determine associations between a graded approach to intravenous (IV) dextrose treatment for neonatal hypoglycemia and changes in blood glucose (BG), length of stay (LOS), and cost of care. STUDY DESIGN: Retrospective cohort study of 277 infants born at ≥35 weeks of gestation in an urban academic delivery hospital, comparing the change in BG after IV dextrose initiation, neonatal intensive care unit (NICU) LOS, and cost of care in epochs before and after a hospital protocol change. During epoch 1, all infants who needed IV dextrose for hypoglycemia were given a bolus and started on IV dextrose at 60 mL/kg/day. During epoch 2, infants received IV dextrose at 30 or 60 mL/kg/day based on the degree of hypoglycemia. Differences in BG outcomes, LOS, and cost of hospital care between epochs were compared using adjusted median regression. RESULTS: In epoch 2, the median (IQR) rise in BG after initiating IV dextrose (19 [10, 31] mg/dL) was significantly lower than in epoch 1 (24 [14,37] mg/dL; adjusted ß = -6.0 mg/dL, 95% CI -11.2, -0.8). Time to normoglycemia did not differ significantly between epochs. NICU days decreased from a median (IQR) of 4.5 (2.1, 11.0) to 3.0 (1.5, 6.5) (adjusted ß = -1.9, 95% CI -3.0, -0.7). Costs associated with NICU hospitalization decreased from a median (IQR) $14 030 ($5847, $30 753) to $8470 ($5650, $19 019) (adjusted ß = -$4417, 95% CI -$571, -$8263) after guideline implementation. CONCLUSIONS: A graded approach to IV dextrose was associated with decreased BG lability and length and cost of NICU stay for infants with neonatal hypoglycemia.


Assuntos
Glicemia/metabolismo , Glucose/administração & dosagem , Custos Hospitalares/estatística & dados numéricos , Hipoglicemia/tratamento farmacológico , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Edulcorantes/administração & dosagem , Administração Intravenosa , Biomarcadores/sangue , Boston , Esquema de Medicação , Feminino , Glucose/economia , Glucose/uso terapêutico , Humanos , Hipoglicemia/sangue , Hipoglicemia/diagnóstico , Hipoglicemia/economia , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/economia , Tempo de Internação/economia , Masculino , Estudos Retrospectivos , Edulcorantes/economia , Edulcorantes/uso terapêutico , Resultado do Tratamento
11.
Semin Fetal Neonatal Med ; 25(6): 101179, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33277220

RESUMO

In a formal economic evaluation ancillary to the Caffeine for Apnea of Prematurity trial, caffeine was shown to reduce costs while simultaneously improving clinical outcomes. Although these results still apply, the current price of caffeine is substantially higher than when it was introduced. Such pharmaceutical price growth contributes appreciably to medical costs and inflation. In this review, the examples of caffeine and surfactant show how prices are determined for the neonatology formulary. Drivers include small market size, government-imposed barriers to competition designed to encourage innovation, high willingness-to-pay, failure of government buyers to exercise their market power, and asymmetries in knowledge about costs and effects between producers and patients. Many of these factors are exercised at the national policy or market levels. However, by conducting rigorous clinical trials and economic evaluations, neonatologists can still ensure that the drugs they prescribe are both efficacious and represent good use of societal resources.


Assuntos
Cafeína/economia , Cafeína/uso terapêutico , Citratos/economia , Citratos/uso terapêutico , Doenças do Prematuro/tratamento farmacológico , Doenças do Prematuro/economia , Controle de Custos , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Recém-Nascido , Medicamentos sob Prescrição/economia
12.
J Perinatol ; 40(7): 1100-1108, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32111976

RESUMO

IMPORTANCE: The Postnatal Growth and Retinopathy of Prematurity (G-ROP) Study showed that the addition of postnatal weight gain to birth weight and gestational age detects similar numbers of infants with ROP, but requires examination of fewer infants. OBJECTIVE: To determine the incremental cost-effectiveness of screening with G-ROP compared with conventional screening. DESIGN, SETTING AND PARTICIPANTS: We built a microsimulation model of a 1-year US birth cohort <32 weeks gestation, using data from the G-ROP study. We obtained resource utilization estimates from the G-ROP dataset and from secondary sources, and test characteristics from the G-ROP cohort. RESULTS: Among 78,281 infants nationally, screening with G-ROP detected ~25 additional infants with Type 1 ROP. This was accomplished with 36,233 fewer examinations, in 14,073 fewer infants, with annual cost savings of approximately US$2,931,980 through hospital discharge. CONCLUSIONS: Screening with G-ROP reduced costs while increasing the detection of ROP compared with current screening guidelines.


Assuntos
Retinopatia da Prematuridade , Peso ao Nascer , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Triagem Neonatal , Retinopatia da Prematuridade/diagnóstico , Retinopatia da Prematuridade/epidemiologia , Estudos Retrospectivos , Fatores de Risco
13.
J Perinatol ; 40(7): 1091-1099, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32103158

RESUMO

The growth in healthcare spending is an important topic in the United States, and preterm and low-birthweight infants have some of the highest healthcare expenditures of any patient population. We performed a retrospective cohort study of spending in this population using a large, national claims database of commercially insured individuals. A total of 763,566 infants with insurance coverage through Aetna, Inc. for the first 6 months of post-natal life were included, and received approximately $8.4 billion (2016 USD) in healthcare services. Infants with billing codes indicating preterm status (<37 weeks, n = 50,511) incurred medical expenditures of $76,153 on average, while low-birthweight status (<2500 g) was associated with average spending of $114,437. Infants born at 24 weeks gestation (n = 418) had the highest per infant average expenditures of $603,778. Understanding the drivers of variation in costs within gestational age and birthweight bands is an important target for future studies.


Assuntos
Gravidez Múltipla , Nascimento Prematuro , Peso ao Nascer , Feminino , Gastos em Saúde , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Gravidez , Resultado da Gravidez , Técnicas de Reprodução Assistida , Estudos Retrospectivos , Estados Unidos
14.
JAMA Pediatr ; 173(5): 462-468, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30855640

RESUMO

Importance: Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known. Objective: To compare the cost-effectiveness of treatment with antenatal corticosteroids with no treatment for women at risk for late preterm delivery. Design, Setting, and Participants: This secondary analysis of the Antenatal Late Preterm Steroids trial, a multicenter randomized clinical trial of antenatal corticosteroids vs placebo in women at risk for late preterm delivery conducted from October 30, 2010, to February 27, 2015. took a third-party payer perspective. Maternal costs were based on Medicaid rates and included those of betamethasone, as well as the outpatient visits or inpatient stay required to administer betamethasone. All direct medical costs for newborn care were included. For infants admitted to the neonatal intensive care unit, comprehensive daily costs were stratified by the acuity of respiratory illness. For infants admitted to the regular newborn nursery, nationally representative cost estimates from the literature were used. Effectiveness was measured as the proportion of infants without the primary outcome of the study: a composite of treatment in the first 72 hours of continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation. This secondary analysis was initially started in June 2016 and revision of the analysis began in May 2017. Exposures: Betamethasone treatment. Main Outcomes and Measures: Incremental cost-effectiveness ratio. Results: Costs were determined for 1426 mother-infant pairs in the betamethasone group (mean [SD] maternal age, 28.6 [6.3] years; 827 [58.0%] white) and 1395 mother-infant pairs in the placebo group (mean [SD] maternal age, 27.9 [6.2] years; 794 [56.9%] white). Treatment with betamethasone was associated with a total mean (SD) woman-infant-pair cost of $4681 ($5798), which was significantly less than the mean (SD) amount of $5379 ($8422) for women and infants in the placebo group (difference, $698; 95% CI, $186-$1257; P = .02). The Antenatal Late Preterm Steroids trial determined that betamethasone use is effective: respiratory morbidity decreased by 2.9% (95% CI, -0.5% to -5.4%). Thus, the cost-effectiveness ratio was -$23 986 per case of respiratory morbidity averted. Inspection of the bootstrap replications confirmed that treatment was the dominant strategy in 5000 samples (98.8%). Sensitivity analyses showed that these results held under most assumptions. Conclusions and Relevance: The findings suggest that antenatal betamethasone treatment is associated with a statistically significant decrease in health care costs and with improved outcomes; thus, this treatment may be an economically desirable strategy.


Assuntos
Betametasona/uso terapêutico , Análise Custo-Benefício , Glucocorticoides/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Nascimento Prematuro/economia , Cuidado Pré-Natal/economia , Síndrome do Desconforto Respiratório do Recém-Nascido/prevenção & controle , Adulto , Betametasona/economia , Esquema de Medicação , Feminino , Seguimentos , Glucocorticoides/economia , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Gravidez , Cuidado Pré-Natal/métodos , Síndrome do Desconforto Respiratório do Recém-Nascido/economia , Medição de Risco , Estados Unidos
15.
Trials ; 20(1): 63, 2019 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-30658678

RESUMO

BACKGROUND: At birth, the majority of neonates born at <30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP). METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness. DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Recém-Nascido Prematuro , Pulmão/fisiopatologia , Nascimento Prematuro , Respiração , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Peso ao Nascer , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Pressão Positiva Contínua nas Vias Aéreas/economia , Análise Custo-Benefício , Idade Gestacional , Custos de Cuidados de Saúde , Humanos , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Intubação Intratraqueal , Estudos Multicêntricos como Assunto , Ohio , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome do Desconforto Respiratório do Recém-Nascido/complicações , Síndrome do Desconforto Respiratório do Recém-Nascido/economia , Síndrome do Desconforto Respiratório do Recém-Nascido/fisiopatologia , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/fisiopatologia , Insuficiência Respiratória/terapia , Fatores de Tempo , Resultado do Tratamento
16.
J Perinatol ; 39(1): 86-94, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30353082

RESUMO

OBJECTIVE: We studied decision making regarding inhaled nitric oxide (iNO) in preterm infants with Pulmonary Hypertension (PH). STUDY DESIGN: We asked members of the AAP-Society of Neonatal-Perinatal Medicine and Division-Chiefs to select from three management options- initiate iNO, engage parents in shared decision making or not consider iNO in an extremely preterm with PH followed by rating of factors influencing their decision. RESULTS: Three hundred and four respondents (9%) completed the survey; 36.5% chose to initiate iNO, 42% to engage parents, and 21.5% did not consider iNO. Provider's prior experience, safety, and patient-centered care were rated higher by those who initiated or offered iNO; lack of effectiveness and cost considerations by participants who did not chose iNO. CONCLUSIONS: Most neonatologists offer or initiate iNO therapy based on their individual experience. The minority who chose not to consider iNO placed higher value on lack of effectiveness and cost. These results demonstrate a tension between evidence and pathophysiology-based-therapy/personal experience.


Assuntos
Tomada de Decisão Clínica/métodos , Hipertensão Pulmonar , Doenças do Prematuro/terapia , Terapia Intensiva Neonatal , Óxido Nítrico/uso terapêutico , Insuficiência Respiratória , Administração por Inalação , Atitude do Pessoal de Saúde , Análise Custo-Benefício , Medicina Baseada em Evidências , Feminino , Humanos , Hipertensão Pulmonar/etiologia , Hipertensão Pulmonar/terapia , Lactente Extremamente Prematuro , Recém-Nascido , Terapia Intensiva Neonatal/métodos , Terapia Intensiva Neonatal/normas , Masculino , Neonatologia/métodos , Neonatologia/normas , Guias de Prática Clínica como Assunto , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/terapia , Estados Unidos
17.
Clin Perinatol ; 45(3): 557-563, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30144855

RESUMO

To date, outcomes in neonatology have focused mainly on the biological outcomes of the babies under our care. In this article, we argue that we must move beyond this proband and biological bias, towards a "Slow Medicine" that recognizes the distinction between the remarkable technical capabilities of the modern medical world and how those intersect with our society, and its values, more broadly. Practically speaking, this involves consideration of the impacts of neonatal intensive care and its sequelae on families, as well as non-biological outcomes such as finances and stress. Implementing this Slow Medicine does not mean that neonatologists must forego effective therapy or the improved mortality and morbidity it has brought, but rather that we adopt a committed and compassionate view of medicine, in which we engage outside the neonatal intensive care unit to address the nonbiological suffering of our patients and their equally vulnerable families.


Assuntos
Efeitos Psicossociais da Doença , Saúde da Família , Família , Doenças do Prematuro , Saúde Mental , Status Econômico , Gastos em Saúde , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Terapia Intensiva Neonatal , Deficiências da Aprendizagem , Transtornos Mentais , Neonatologia , Estresse Psicológico
18.
Semin Fetal Neonatal Med ; 23(6): 416-419, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30145059

RESUMO

Necrotizing enterocolitis (NEC), a common morbidity of prematurity, affects 5-10% of premature infants with a birthweight <1500 g. The added cost remains unclear. Multiple studies report the cost of care for an infant with NEC as higher than that of well premature infants, but these studies are fraught with limitations. Surgical intervention and type of surgery appear to impact overall costs. Health care resource utilization extends beyond the birth hospitalization, particularly in those infants requiring surgery, and persists to at least three years of age. This narrative review of the literature reveals a paucity of studies and significant methodological deficiencies in most included studies. Further studies of the cost of NEC need to address the issues of significant confounding in this complex population.


Assuntos
Enterocolite Necrosante/economia , Custos de Cuidados de Saúde , Humanos , Recém-Nascido , Recém-Nascido Prematuro
19.
Pediatrics ; 141(3)2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29490909

RESUMO

OBJECTIVES: To determine the cost-effectiveness of supplemental donor human milk (DHM) versus preterm formula (PTF) for very low birth weight (VLBW, <1500 g) infants from a societal perspective to 18 months' corrected age. METHODS: This prospective cost-effectiveness analysis of 363 VLBW infants was conducted for a randomized control trial. Infants recruited from October 2010 to December 2012 were fed DHM or PTF whenever mother's milk was unavailable. Formal health care costs for initial hospitalization and readmissions were obtained from standardized cost-accounting systems and physician fees. Informal and nonhealth care sector costs (eg, caregiver transportation, labor market earnings) were calculated from parent reports. RESULTS: Mean infant birth weight was 996 (SD, 272) grams. Incidence of necrotizing enterocolitis (NEC) differed between groups (all stages 3.9% DHM, 11.0% PTF; P = .01). Costs to 18 months did not differ with a mean (95% confidence interval) of 217 624 (197 697-237 551) and 217 245 (196 494-237 995) 2015 Canadian dollars in the DHM and PTF groups. Postdischarge costs were lower in the DHM (46 440 [40 648-52 233]) than PTF group (55 102 [48 269-61 934]) (P = .04), driven by parent lost wages. DHM cost an additional $5328 per case of averted NEC. CONCLUSIONS: In a high mother's milk use setting, total costs from a societal perspective to 18 months of providing supplemental DHM versus PTF to VLBW infants did not differ, although postdischarge costs were lower in the DHM group. Although supplemental DHM was not cost-saving, it reduced NEC supporting its use over PTF.


Assuntos
Análise Custo-Benefício , Fórmulas Infantis/economia , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Leite Humano , Desenvolvimento Infantil , Método Duplo-Cego , Enterocolite Necrosante/prevenção & controle , Seguimentos , Custos de Cuidados de Saúde , Hospitalização/economia , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal/economia , Readmissão do Paciente/economia , Estudos Prospectivos
20.
Clin Perinatol ; 44(3): 617-625, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28802342

RESUMO

Work within the US health care system has sought to improve outcomes, decrease costs, and improve the patient experience. Combining those three elements leads to value-added care. Quality improvement within neonatology has focused primarily on the improvement of clinical outcomes without explicit consideration of cost. Future improvement efforts in neonatology should consider opportunities to decrease or eliminate waste, and improve outcomes. Consideration of how a change affects all stakeholders reveals potential cost-saving opportunities, and developing aims with value in mind facilitates understanding and goal-setting with senior administrative leaders.


Assuntos
Terapia Intensiva Neonatal/normas , Neonatologia/normas , Melhoria de Qualidade , Análise Custo-Benefício , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/economia , Unidades de Terapia Intensiva Neonatal/normas , Terapia Intensiva Neonatal/economia , Neonatologia/economia , Estados Unidos
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