RESUMO
OBJECTIVE: To quantify site-specific costs and their association with survival without major morbidity (SWMM) in Canada for neonates <28 weeks of gestation admitted to large tertiary neonatal intensive care units. METHODS: We conducted a retrospective analysis of infants born at <28 weeks of gestation and admitted to Canadian Neonatal Network sites from 2010 through 2021. Sites that cared for at least 50 eligible infants by gestational age in weeks over the study period were included. Using a validated costing algorithm that assessed physician, nursing, respiratory therapy, diagnostic imaging, transfusions, procedural, medication, and certain indirect costs, we calculated site and resource-specific costs in 2017 Canadian dollars (CAD) and evaluated their relationship with SWMM. RESULTS: Seven sites with 8180 (range 841-1605) eligible neonates with a mean (SD) gestation of 25.4 [1.3] weeks were included. Survival to discharge or transfer was 85.3% with a mean (SD) length of stay of 75 (46) days. The mean (SD) total and daily costs per neonate varied between $94â992 ($60â283) and $174â438 ($130â501) CAD and $1833 ($916) to $2307 ($1281) CAD, respectively. Between sites, there was no relationship between costs and SWMM. CONCLUSIONS: There was marked variation in costs and SWMM between sites in Canada with universal health care. The lack of concordance between both outcomes and costs among sites may provide possibilities for outcomes improvement and cost containment.
Assuntos
Lactente Extremamente Prematuro , Unidades de Terapia Intensiva Neonatal , Recém-Nascido , Lactente , Humanos , Estudos Retrospectivos , Canadá , Idade GestacionalRESUMO
OBJECTIVE: To test feasibility and safety of administering sildenafil in neonates with neonatal encephalopathy (NE), developing brain injury despite therapeutic hypothermia (TH). STUDY DESIGN: We performed a randomized, double-blind, placebo-controlled phase Ib clinical trial between 2016 and 2019 in neonates with moderate or severe NE, displaying brain injury on day-2 magnetic resonance imaging (MRI) despite TH. Neonates were randomized (2:1) to 7-day sildenafil or placebo (2 mg/kg/dose enterally every 12 hours, 14 doses). Outcomes included feasibility and safety (primary outcomes), pharmacokinetics (secondary), and day-30 neuroimaging and 18-month neurodevelopment assessments (exploratory). RESULTS: Of the 24 enrolled neonates, 8 were randomized to sildenafil and 3 to placebo. A mild decrease in blood pressure was reported in 2 of the 8 neonates after initial dose, but not with subsequent doses. Sildenafil plasma steady-state concentration was rapidly reached, but decreased after TH discontinuation. Twelve percent of neonates (1/8) neonates died in the sildenafil group and 0% (0/3) in the placebo group. Among surviving neonates, partial recovery of injury, fewer cystic lesions, and less brain volume loss on day-30 magnetic resonance imaging were noted in 71% (5/7) of the sildenafil group and in 0% (0/3) of the placebo group. The rate of death or survival to 18 months with severe neurodevelopmental impairment was 57% (4/7) in the sildenafil group and 100% (3/3) in the placebo group. CONCLUSIONS: Sildenafil was safe and well-absorbed in neonates with NE treated with TH. Optimal dosing needs to be established. Evaluation of a larger number of neonates through subsequent phases II and III trials is required to establish efficacy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.govNCT02812433.
Assuntos
Asfixia Neonatal , Lesões Encefálicas , Hipotermia Induzida , Hipóxia-Isquemia Encefálica , Doenças do Recém-Nascido , Recém-Nascido , Humanos , Citrato de Sildenafila/efeitos adversos , Asfixia/complicações , Estudos de Viabilidade , Asfixia Neonatal/terapia , Lesões Encefálicas/complicações , Lesões Encefálicas/tratamento farmacológico , Doenças do Recém-Nascido/terapia , Hipóxia-Isquemia Encefálica/terapia , Hipotermia Induzida/métodos , Método Duplo-CegoRESUMO
We evaluated the association between left cardiac 3-dimensional echocardiographic parameters and brain injury in a single-center prospective study of neonates with neonatal encephalopathy. On day 2 of life, neonates with brain injury had greater left ventricle end-diastolic and stroke volume but also greater peak global circumferential strain detected by 3-dimensional echocardiogram.
Assuntos
Lesões Encefálicas , Ecocardiografia Tridimensional , Disfunção Ventricular Esquerda , Recém-Nascido , Humanos , Lactente , Função Ventricular Esquerda , Estudos Prospectivos , Ecocardiografia/métodos , Ecocardiografia Tridimensional/métodos , Volume Sistólico , Ventrículos do Coração/diagnóstico por imagem , Lesões Encefálicas/complicações , Lesões Encefálicas/diagnóstico por imagem , Disfunção Ventricular Esquerda/diagnóstico por imagemRESUMO
OBJECTIVE: To evaluate the change in the proportion of deaths/bronchopulmonary dysplasia (BPD) among premature infants (born <26 and 26-29 weeks of gestational age) following a policy change to a strict nonintervention approach, compared with standard treatment. STUDY DESIGN: We examined 1249 infants (341 born <26 weeks of gestational age) at 2 comparable sites. Site 1 (control) continued medical treatment/ligation, and site 2 (exposed) changed to a nonintervention policy in late 2013. Using the difference-in-differences approach, which accounts for time-invariant differences between sites and secular trends, we assessed changes in death or BPD separately among infants born 26-29 weeks and <26 weeks of gestational age in 2 epochs (epoch 1: 2011-2013; epoch 2: 2014-2017). RESULTS: Baseline characteristics were similar across sites and epochs. Medical treatment/ligation use remained stable at site 1 but declined progressively to 0% at site 2, indicating adherence to policy. We saw no difference in death/BPD among infants born at 26-29 weeks of gestational age (12%, 95% CI -1% to 24%). However, incidence of death/BPD increased by 31% among infants born <26 weeks of gestational age (95% CI 10%-51%) in site 2, whereas there was no change in outcomes in site 1. The Score for Neonatal Acute Physiology-Version II, used as a control outcome, did not change in either site, suggesting that our findings were not due to changes in patients' severity. CONCLUSIONS: Adherence to a strict conservative policy did not impact death or BPD among 26 weeks but was associated with a significant rise in infants born <26 weeks.
Assuntos
Displasia Broncopulmonar , Permeabilidade do Canal Arterial , Doenças do Prematuro , Displasia Broncopulmonar/epidemiologia , Displasia Broncopulmonar/terapia , Pré-Escolar , Permeabilidade do Canal Arterial/terapia , Idade Gestacional , Humanos , Lactente , Lactente Extremamente Prematuro , Recém-Nascido , Resultado do TratamentoRESUMO
Persistent pulmonary hypertension of the newborn may occur with perinatal asphyxia, either because of direct effects of hypoxia/ischemia on pulmonary arterial function or indirectly because both are associated with meconium aspiration syndrome or perinatal sepsis/pneumonia. Therapies for persistent pulmonary hypertension of the newborn have the potential to affect cerebral function and cerebral perfusion in infants with hypoxic ischemic encephalopathy. Our literature review concludes that hyperventilation should be avoided, bicarbonate therapy is unproven, and hypoxia and hyperoxia should both be avoided. Nitric oxide improves pulmonary artery pressure and systemic perfusion. The effects of inotropic agents on cerebral perfusion or outcomes are uncertain.