RESUMO
OBJECTIVE: To determine if preterm infants with surgical necrotizing enterocolitis (sNEC) or spontaneous intestinal perforation (SIP) with short bowel syndrome (SBS) have worse neurodevelopmental and growth outcomes than those with sNEC/SIP without SBS, and those with no necrotizing enterocolitis, SIP, or SBS. STUDY DESIGN: We undertook a retrospective analysis of prospectively collected data from infants born between 22 and 26 weeks of gestation in the National Institute of Child Health and Human Development Neonatal Research Network centers from January 1, 2008, to December 31, 2016. Survivors were assessed at 18-26 months corrected age by standardized neurologic examination and Bayley Scales of Infant and Toddler Development, Third Edition. The primary outcome was moderate-severe neurodevelopmental impairment. Growth was assessed using World Health Organization z-score standards. Adjusted relative risks were estimated using modified Poisson regression models. RESULTS: Mortality was 32%, 45%, and 21% in the 3 groups, respectively. Eighty-nine percent of survivors were seen at 18-26 months corrected age. Moderate-severe neurodevelopmental impairment was present in 77% of children with SBS compared with 62% with sNEC/SIP without SBS (adjusted relative risk, 1.22; 95% CI, 1.02-1.45; P = .03) and 44% with no necrotizing enterocolitis, SIP, or SBS (adjusted relative risk, 1.60; 95% CI, 1.37-1.88; P < .001). Children with SBS had lowcognitive, language, and motor scores than children with sNEC/SIP without SBS. At follow-up, length and head circumference z-scores remained more than 1 SD below the mean for children with SBS. CONCLUSIONS: Preterm infants with sNEC/SIP and SBS had increased risk of adverse neurodevelopmental outcomes at 18-26 months corrected age and impaired growth compared with peers with sNEC/SIP without SBS or without any of these conditions.
Assuntos
Deficiências do Desenvolvimento/etiologia , Enterocolite Necrosante/epidemiologia , Perfuração Intestinal/epidemiologia , Síndrome do Intestino Curto/epidemiologia , Adulto , Estudos de Casos e Controles , Pré-Escolar , Comorbidade , Deficiências do Desenvolvimento/epidemiologia , Feminino , Idade Gestacional , Humanos , Lactente , Lactente Extremamente Prematuro , Doenças do Prematuro/epidemiologia , Masculino , Estudos RetrospectivosRESUMO
OBJECTIVE: To determine safety and pharmacodynamics/efficacy of teduglutide in children with intestinal failure associated with short bowel syndrome (SBS-IF). STUDY DESIGN: This 12-week, open-label study enrolled patients aged 1-17 years with SBS-IF who required parenteral nutrition (PN) and showed minimal or no advance in enteral nutrition (EN) feeds. Patients enrolled sequentially into 3 teduglutide cohorts (0.0125 mg/kg/d [n = 8], 0.025 mg/kg/d [n = 14], 0.05 mg/kg/d [n = 15]) or received standard of care (SOC, n = 5). Descriptive summary statistics were used. RESULTS: All patients experienced ≥1 treatment-emergent adverse event; most were mild or moderate. No serious teduglutide-related treatment-emergent adverse events occurred. Between baseline and week 12, prescribed PN volume and calories (kcal/kg/d) changed by a median of -41% and -45%, respectively, with 0.025 mg/kg/d teduglutide and by -25% and -52% with 0.05 mg/kg/d teduglutide. In contrast, PN volume and calories changed by 0% and -6%, respectively, with 0.0125 mg/kg/d teduglutide and by 0% and -1% with SOC. Per patient diary data, EN volume increased by a median of 22%, 32%, and 40% in the 0.0125, 0.025, and 0.05 mg/kg/d cohorts, respectively, and by 11% with SOC. Four patients achieved independence from PN, 3 in the 0.05 mg/kg/d cohort and 1 in the 0.025 mg/kg/d cohort. Study limitations included its short-term, open-label design, and small sample size. CONCLUSIONS: Teduglutide was well tolerated in pediatric patients with SBS-IF. Teduglutide 0.025 or 0.05 mg/kg/d was associated with trends toward reductions in PN requirements and advancements in EN feeding in children with SBS-IF. TRIAL REGISTRATION: ClinicalTrials.gov:NCT01952080; EudraCT: 2013-004588-30.
Assuntos
Nutrição Enteral/métodos , Peptídeos/administração & dosagem , Síndrome do Intestino Curto/tratamento farmacológico , Adolescente , Fatores Etários , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Seguimentos , Humanos , Masculino , Segurança do Paciente , Peptídeos/efeitos adversos , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Síndrome do Intestino Curto/diagnóstico , Síndrome do Intestino Curto/terapia , Resultado do TratamentoRESUMO
OBJECTIVES: To determine the prevalence of deficiencies of specific micronutrients (iron, zinc, magnesium, phosphorus, selenium, copper, folate, and vitamins A, D, E, and B12) in children with intestinal failure (IF), and to identify risk factors associated with developing these deficiencies. STUDY DESIGN: This study was a retrospective review of prospectively collected data from 178 children with IF managed by the Intestinal Care Center of Cincinnati Children's Hospital Medical Center between August 1, 2007, and July 31, 2012. Transition to full enteral nutrition (FEN) was defined as the period during which the patient received between 20% and 100% of estimated required nutrition enterally. FEN was defined as the patient's ability to tolerate 100% estimated required nutrition enterally for >2 weeks. RESULTS: Necrotizing enterocolitis was the most common cause of IF (27.5%). Iron was the most common micronutrient deficiency identified both during (83.9%) and after (61%) successful transition to FEN, with a significant reduction in the percentage of patients with iron deficiency between these 2 periods (P = .003). Predictors of micronutrient deficiency after successful transition to FEN included birth weight (P = .03), weight percentile (P = .02), height percentile (P = .04), and duration of parenteral nutrition (PN) (P = .013). After multivariate adjustments, only duration of PN remained statistically significant (P = .03). CONCLUSION: Micronutrient deficiencies persist in patients with IF during and after transition to FEN. These data support the need for routine monitoring and supplementation of these patients, especially those on prolonged PN.
Assuntos
Nutrição Enteral , Enteropatias/terapia , Micronutrientes/deficiência , Pré-Escolar , Deficiências Nutricionais/epidemiologia , Deficiências Nutricionais/etiologia , Feminino , Humanos , Enteropatias/complicações , Masculino , Prevalência , Estudos RetrospectivosRESUMO
OBJETIVO: Avaliar a incidência de doenças diarreicas (DA) e infecção respiratória aguda (IRA) em crianças submetidas à suplementação de zinco e outros micronutrientes através dos sprinkles, bem como a aceitação destes pelos participantes. MÉTODO: Ensaio clínico, duplo cego, randomizado, realizado com 143 crianças institucionalizadas, saudáveis, de seis a 48 meses. As mesmas foram randomizadas em dois grupos e receberam diariamente zinco + micronutrientes - grupo teste (sprinkles), ou apenas micronutrientes sem zinco - grupo controle. As crianças foram suplementadas por 90 dias e acompanhadas quanto aos desfechos de DA e IRA. RESULTADOS: Das crianças randomizadas, 52,45% pertenciam ao grupo teste e 47,55% ao controle. A incidência de DA no teste foi de 14,7%, e no controle, 19,1%. O grupo teste apresentou menor risco de desenvolver DA em relação ao controle, porém esse achado não foi estatisticamente significante (RR = 0,77 [0,37-1,6]; p = 0,5088). A IRA apresentou incidência elevada em ambos os grupos, sendo 60% no teste e 48,5% no controle, com risco maior de apresentar a doença no grupo teste, porém sem significância estatística (RR=1,24 [0,91-1,68]; p = 0,1825). Quanto à aceitação, o percentual médio de consumo, em dias, de todo conteúdo dos sachês contendo sprinkles foi 95,72% (DP = 4,9) e 96,4% (DP = 6,2), para o teste e controle, respectivamente. CONCLUSÕES: A suplementação de zinco através dos sprinkles não reduziu a incidência de DA ou IRA entre as crianças avaliadas. Os sprinkles foram bem aceitos por todos os participantes do estudo.
OBJECTIVE: To evaluate the incidence of diarrheal disease (DD) and acute respiratory infection (ARI) in children undergoing supplementation of zinc and other micronutrients through the use of sprinkles, as well as their acceptance by these participants. METHOD: This was a randomized double-blinded clinical trial of 143 healthy institutionalized children, aged 6 to 48 months. They were randomized into two groups and received daily zinc and micronutrients - test group (sprinkles), or micronutrients without zinc - control group. Children were supplemented for 90 days and followed regarding the outcomes of DD and ARI. RESULTS: Of the randomized children, 52.45% belonged to the test and 47.55% to the control group. The incidence of DD in the test group was 14.7% and was 19.1% in the control group. The test group showed a lower risk of developing DD when compared to controls, but this finding was not statistically significant (RR = 0.77 [0.37 to 1.6], p = 0.5088). ARI had high incidence in both groups, 60% in the test group and 48.5% in the control group, with an increased risk of developing the disease in the test group, but with no statistical significance (RR = 1.24 [0.91 to 1.68], p = 0.1825). Regarding acceptance, the mean percentage of consumption, in days, of the entire content of the sachets containing sprinkles was 95.72% (SD = 4.9) and 96.4% (SD = 6.2) for the test and control groups, respectively. CONCLUSIONS: Zinc supplementation through the use of sprinkles did not reduce the incidence of DD or ARI among the evaluated children. The sprinkles were well accepted by all study participants.
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Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Criança Institucionalizada , Suplementos Nutricionais , Diarreia/prevenção & controle , Micronutrientes/administração & dosagem , Infecções Respiratórias/prevenção & controle , Zinco/administração & dosagem , Zinco/deficiência , Criança Institucionalizada/estatística & dados numéricos , Diarreia/epidemiologia , Suplementos Nutricionais/efeitos adversos , Suplementos Nutricionais/classificação , Métodos Epidemiológicos , Alimentos em Conserva/efeitos adversos , Infecções Respiratórias/epidemiologiaRESUMO
OBJECTIVE: To evaluate the incidence of diarrheal disease (DD) and acute respiratory infection (ARI) in children undergoing supplementation of zinc and other micronutrients through the use of sprinkles, as well as their acceptance by these patients. METHOD: This was a randomized double-blinded clinical trial of 143 healthy institutionalized children, aged 6 to 48 months. They were randomized into two groups and received daily zinc and micronutrients - test group (sprinkles), or micronutrients without zinc - control group. Children were supplemented for 90 days and followed regarding the outcomes of DD and ARI. RESULTS: Of the randomized children, 52.45% belonged to the test and 47.55% to the control group. The incidence of DD in the test group was 14.7% and was 19.1% in the control group. The test group showed a lower risk of developing DD when compared to controls, but this finding was not statistically significant (RR=0.77 [0.37 to 1.6], p=0.5088). ARI had high incidence in both groups, 60% in the test group and 48.5% in the control group, with an increased risk of developing the disease in the test group, but with no statistical significance (RR=1.24 [0.91 to 1.68], p=0.1825). Regarding acceptance, the mean percentage of consumption, in days, of the entire content of the sachets containing sprinkles was 95.72% (SD=4.9) and 96.4% (SD=6.2) for the test and control groups, respectively. CONCLUSIONS: Zinc supplementation through the use of sprinkles did not reduce the incidence of DD or ARI among the evaluated children. The sprinkles were well accepted by all study participants.
Assuntos
Criança Institucionalizada , Diarreia/prevenção & controle , Suplementos Nutricionais , Micronutrientes/administração & dosagem , Infecções Respiratórias/prevenção & controle , Zinco/administração & dosagem , Zinco/deficiência , Criança Institucionalizada/estatística & dados numéricos , Pré-Escolar , Diarreia/epidemiologia , Suplementos Nutricionais/efeitos adversos , Suplementos Nutricionais/classificação , Métodos Epidemiológicos , Feminino , Alimentos em Conserva/efeitos adversos , Humanos , Lactente , Masculino , Infecções Respiratórias/epidemiologiaRESUMO
OBJECTIVE: To examine pathogens and other characteristics associated with late-onset bloodstream infections (BSIs) in infants with intestinal failure (IF) as a consequence of necrotizing enterocolitis (NEC). STUDY DESIGN: Infants weighing 401-1500 g at birth who survived for >72 hours and received care at Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers were studied. The frequency of culture-positive BSI and pathogens were compared in infants with medically managed NEC, NEC managed surgically without IF, and surgical IF. Among infants with IF, the duration of parenteral nutrition (PN) and other outcomes were evaluated. RESULTS: A total of 932 infants were studied (IF, n = 78; surgical NEC without IF, n = 452; medical NEC, n = 402). The proportion with BSI after diagnosis of NEC was higher in the infants with IF than in those with surgical NEC (P = .007) or medical NEC (P < .001). Gram-positive pathogens were most frequent. Among infants with IF, an increased number of infections was associated with longer hospitalization and duration of PN (median stay: 172 for those with 0 infections, 188 days for those with 1 infection, and 260 days for those with ≥2 infections [P = .06]; median duration of PN: 90, 112, and 115 days, respectively [P = .003]) and decreased achievement of full feeds during hospitalization (87%, 67%, and 50%, respectively; P = .03). CONCLUSION: Recurrent BSIs are common in very low birth weight infants with IF. Gram-positive bacteria were the most commonly identified organisms in these infants.
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Enterocolite Necrosante/complicações , Enterocolite Necrosante/epidemiologia , Síndrome do Intestino Curto/complicações , Patógenos Transmitidos pelo Sangue , Humanos , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Estudos ProspectivosRESUMO
Anemia is a significant health concern worldwide and can be the result of nutritional, environmental, social, and infectious etiologies. We estimated the prevalence of anemia in 336 pre-school children and 132 adults in the rural Central Plateau of Haiti and assessed associations with age, sex, household size, water source, sanitation, and Helicobacter pylori seroreactivity using logistic regression analysis; 80.1% (269/336) of children and 63.6% (84/132) of adults were anemic. Among children, younger age was associated with increased prevalence of anemia (adjusted odds ratio [aOR] = 4.1, 95% confidence interval [CI] = 1.5-11.1 for children 6-11 months compared with children 48-59 months). Among adults, 50.8% were H. pylori-seropositive, and seropositivity was inversely associated with anemia (aOR = 0.4, 95% CI = 0.2-0.9). Anemia prevalence in this region of Haiti is very high and not attributable to sanitary conditions or a high prevalence of H. pylori infection.
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Anemia/epidemiologia , Anemia/etiologia , Infecções por Helicobacter/sangue , Infecções por Helicobacter/complicações , Helicobacter pylori , Adolescente , Adulto , Idoso , Anticorpos Antibacterianos/sangue , Pré-Escolar , Estudos Transversais , Feminino , Haiti/epidemiologia , Infecções por Helicobacter/epidemiologia , Helicobacter pylori/imunologia , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Razão de Chances , Prevalência , População Rural , Adulto JovemRESUMO
OBJECTIVE: This pilot study in parenteral nutrition-dependent infants with short bowel syndrome (SBS) evaluated the impact of feeding route and intestinal permeability on bloodstream infection (BSI), small bowel bacterial overgrowth (SBBO), and systemic immune responses, as well as fecal calprotectin as a biomarker for SBBO. STUDY DESIGN: Ten infants (ages 4.2-15.4 months) with SBS caused by necrotizing enterocolitis were evaluated. Nutritional assessment, breath hydrogen testing, intestinal permeability, fecal calprotectin, serum flagellin- and lipopolysaccharide-specific antibody titers, and proinflammatory cytokine concentrations (tumor necrosis factor-alpha [TNF-alpha], interleukin-1 beta, -6, and -8) were performed at baseline and at 60 and 120 days. Healthy, age-matched control subjects (n = 5) were recruited. RESULTS: BSI incidence was high (80%), and SBBO was common (50%). SBBO increased the odds for BSI (>7-fold; P = .009). Calprotectin levels were higher in children with SBS and SBBO versus those without SBBO and healthy control subjects (P < .05). Serum TNF-alpha, was elevated at baseline versus controls. Serum TNF-alpha and interleukin-1 beta, -6, and -8 levels diminished with increased enteral nutrition. Anti-flagellin and anti-lipopolysaccharide immunoglobulin G levels in children with SBS were lower versus control subjects and rose over time. CONCLUSION: In children with SBS, SBBO increases the risk for BSI, and systemic proinflammatory response decreases with increasing enteral feeding and weaning parenteral nutrition.
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Intestino Delgado/microbiologia , Sepse/sangue , Síndrome do Intestino Curto/epidemiologia , Nutrição Enteral , Enterocolite Necrosante/cirurgia , Fezes/química , Feminino , Flagelina/sangue , Humanos , Incidência , Lactente , Interleucina-1beta/sangue , Interleucina-6/sangue , Interleucina-8/sangue , Complexo Antígeno L1 Leucocitário/análise , Masculino , Projetos Piloto , Sepse/epidemiologia , Fator de Necrose Tumoral alfa/sangueRESUMO
OBJECTIVE: To apply the principles of statistical process control (SPC) to manage calcineurin inhibitor (CNI) blood levels. We hypothesized that the use of SPC would increase the proportion of CNI blood levels in the target range. STUDY DESIGN: The study population consisted of 217 patients more than 3 months after liver transplantation. After demonstration of proof of concept using the rapid cycle improvement process, SPC was applied to the entire population. The change package included definition of target ranges for CNI, implementation of a web-based tool that displayed CNI blood levels on a control chart, and implementation of a protocol and a checklist for management of CNI blood levels. The principal outcome measure was the proportion of CNI blood levels in the target range. RESULTS: In the pilot study, the proportion of CNI blood levels in the target range increased from 50% to 85%. When the protocol was spread to the entire population, the proportion of drug levels in the target range increased to 77% from 50% (P < .001), whereas the range of CNI levels decreased. The rate of allograft rejection did not change. CONCLUSIONS: Utilization of SPC increased the proportion of CNI blood levels in target range. These observations may be applicable to the care of other chronic healthcare problems.
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Inibidores de Calcineurina , Inibidores Enzimáticos/sangue , Imunossupressores/sangue , Transplante de Fígado , Estatística como Assunto , Assistência Ambulatorial , Pré-Escolar , Protocolos Clínicos , Ciclosporina/sangue , Ciclosporina/uso terapêutico , Inibidores Enzimáticos/uso terapêutico , Feminino , Rejeição de Enxerto/prevenção & controle , Humanos , Imunossupressores/uso terapêutico , Masculino , Ohio , Projetos Piloto , Garantia da Qualidade dos Cuidados de Saúde , Tacrolimo/sangue , Tacrolimo/uso terapêuticoRESUMO
OBJECTIVE: To compare the direct health care cost of living donor liver transplantation (LDLT) with that of cadaver donor liver transplantation (CDLT) in children and identify predictors of cost. STUDY DESIGN: All 16 children who underwent LDLT from January 1997 through January 2002 at Cincinnati Children's Hospital Medical Center comprised the study population. They were matched for age, diagnosis, and nutritional status with 31 children who received CDLT during the same era. A historic cohort analysis was performed. RESULTS: There was no difference in the 1-year mortality rates between both groups. Costs associated with graft retrieval contributed 15.3% and 31% of the initial transplant cost for LDLT and CDLT, respectively. Mean cost of care in the first year was 60.3% higher for LDLT than CDLT (P=.01). Multivariate analysis identified biliary complications and insurance status as predictors of cost for initial transplantation (R(2)=0.57), whereas biliary complications and pediatric end stage liver disease scores were identified as predictors of cost of care in the first year after transplantation (R(2)=0.77). CONCLUSIONS: The comprehensive cost of LDLT in the first year after transplantation is higher than cadaveric transplantation. This must be balanced against the time spent and care needs of patients on the waiting list.