Aplicação de protocolo proposto pela Agência Nacional de Vigilância Sanitária para uso de antibióticos em recém-nascidos de muito baixo peso / Implementation of a protocol proposed by the brazilian National Health Surveillance Agency for antibiotic use in very low birth weight infants

OBJETIVO: Analisar a aplicação de um protocolo proposto pela Agência Nacional de Vigilância Sanitária (ANVISA) para aprimorar o diagnóstico de sepse em recém-nascidos de muito baixo peso. MÉTODOS: Estudo prospectivo que avaliou a aplicação de protocolo envolvendo critérios clínicos e laboratoriais (escore hematológico de Rodwell e dosagem seriada da proteína C-reativa), recomendado pela ANVISA, para aprimorar o diagnóstico de sepse neonatal em recém-nascidos de muito baixo peso. Participaram do estudo todos os pacientes que nasceram e permaneceram na Unidade Neonatal até a alta ou óbito, e foram excluídos aqueles com doenças congênitas. Os principais desfechos analisados entre os recém-nascidos antes da aplicação do protocolo (2006-2007) e após a aplicação do mesmo (2008) foram as taxas de sepses precoce e tardia, o uso de antimicrobianos e a mortalidade. As médias foram comparadas por meio de teste t e as variáveis categóricas pelo teste Qui-quadrado (χ2); o nível de significância para todos eles foi fixado em 95%. RESULTADOS: Foram incluídos no estudo 136 recém-nascidos de muito baixo peso. Não houve diferença entre os grupos em relação às características clínicas gerais nos períodos estudados. Houve, no entanto, redução na quantidade de diagnóstico de sepse precoce provável (p < 0,001), de uso de esquemas antimicrobianos (p < 0,001) e da mortalidade geral e associada à sepse (p = 0,009 e p = 0,049, respectivamente). CONCLUSÃO: A utilização do protocolo permitiu aprimorar o diagnóstico de sepse, reduzindo o diagnóstico de sepse precoce provável, promovendo, desta forma, o uso racional de antimicrobianos na população estudada.

OBJECTIVE: To analyze the implementation of a protocol proposed by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA) to improve sepsis diagnosis in very low birth weight newborns. METHODS: This was a prospective study that evaluated the implementation of a protocol involving clinical and laboratory criteria (hematologic scoring system of Rodwell and C-reactive protein serial measurements), recommended by ANVISA, to improve the diagnosis of neonatal sepsis in very low birth weight newborns. The study included all patients who were born and remained in the neonatal intensive care unit until discharge or death, and excluded those with congenital diseases. The main outcomes measured in newborns before (2006-2007) and after implementation of the protocol (2008) were the rates of early and late sepsis, use of antibiotics, and mortality. Means were compared by Student's t-test and categorical variables were compared by the chi-squared test; the significance level for all tests was set at 95%. RESULTS: The study included 136 newborns with very low birth weight. There was no difference between groups regarding general clinical characteristics in the studied periods. There was, however, a decrease in the number of diagnoses of probable early-onset sepsis (p < 0.001), use of antimicrobial regimens (p < 0.001), and overall mortality and infection-related mortality (p = 0.009 and p = 0.049, respectively). CONCLUSION: The implementation of the protocol allowed improvement of sepsis diagnosis by reducing the diagnosis of probable early-onset sepsis, thus promoting efficient antimicrobial use in this population.

Implementation of a protocol proposed by the Brazilian National Health Surveillance Agency for antibiotic use in very low birth weight infants.

OBJECTIVE: To analyze the implementation of a protocol proposed by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA) to improve sepsis diagnosis in very low birth weight newborns. METHODS: This was a prospective study that evaluated the implementation of a protocol involving clinical and laboratory criteria (hematologic scoring system of Rodwell and C-reactive protein serial measurements), recommended by ANVISA, to improve the diagnosis of neonatal sepsis in very low birth weight newborns. The study included all patients who were born and remained in the neonatal intensive care unit until discharge or death, and excluded those with congenital diseases. The main outcomes measured in newborns before (2006-2007) and after implementation of the protocol (2008) were the rates of early and late-onset sepsis, use of antibiotics, and mortality. Means were compared by Student's t-test and categorical variables were compared by the chi-squared test; the significance level for all tests was set at 95%. RESULTS: The study included 136 newborns with very low birth weight. There was no difference between groups regarding general clinical characteristics in the studied periods. There was, however, a decrease in the number of diagnoses of probable early-onset sepsis (p<0.001), use of antimicrobial regimens (p<0.001), and overall mortality and infection-related mortality (p=0.009 and p=0.049, respectively). CONCLUSION: The implementation of the protocol allowed improvement of sepsis diagnosis by reducing the diagnosis of probable early-onset sepsis, thus promoting efficient antimicrobial use in this population.

Very late onset infections in the neonatal intensive care unit.

OBJECTIVE: We sought to determine the risk factors, incidence, and mortality of very late onset bacterial infection (blood, urine, or cerebrospinal fluid culture positive occurring after day of life 120) in preterm infants. STUDY DESIGN: A retrospective observational cohort study of all very low birth weight infants cared for between day of life 120 and 365 in 292 neonatal intensive care units in the United States from 1997 to 2008. RESULTS: We identified 3918 infants who were hospitalized beyond 120 days of life. Of these, 1027 (26%) were evaluated with at least 1 culture (blood, urine, or cerebrospinal fluid), and 276 (27%) of the evaluated infants had 414 episodes of culture-positive infection. Gram-positive organisms caused most of the infections (48%). The risk of death was higher in infants with positive cultures (odds ratio; 10.5, 95% confidence interval [7.2-15.5]) or negative cultures (4.8, [3.5-6.7]) compared to infants that were never evaluated with a culture (p<0.001). Mortality was highest with fungal infections (8/24, 33%) followed by Gram-positive cocci (40/142, 28%). CONCLUSIONS: Important predictive risk factors for early and late onset sepsis (birth weight and gestational age) did not contribute to risk of developing very late onset infection. Evaluation for infection (whether positive or negative) was a significant risk factor for death. GPC and fungal infections were associated with high mortality.

Intracranial pressure changes during intermittent CSF drainage.

Premature very-low-birth-weight infants with posthemorrhagic hydrocephalus are often managed with intermittent cerebrospinal fluid drainage from a ventricular reservoir. There are little data regarding intracranial pressure changes during intermittent drainage to determine the amount and frequency of cerebrospinal fluid removal or to determine the correct resistance of future programmable shunts. The objective of this study was to determine the feasibility of using a commercially available intracranial pressure transducer to measure changes in pressure associated with this procedure. Continuous intracranial pressure was measured in three infants with a transducer placed at the time of ventricular reservoir insertion. Daily reservoir taps began 48 hours after placement and intracranial pressure was monitored for 7 days. Intracranial pressure before the initial tap was comparable to levels previously reported as normal. The daily removal of 10 cc/kg of cerebrospinal fluid was sufficient to lower intracranial pressure below baseline, however it was associated with wide swings in pressure and, in one patient, sustained negative pressure. The use of direct intracranial pressure monitoring may be useful in determining the optimal amount and frequency of cerebrospinal drainage from infants with posthemorrhagic hydrocephalus managed with a ventricular reservoir, as well as determining resistance settings of subsequent programmable shunts.