RESUMO
BACKGROUND: Newborn infants admitted to the neonatal intensive care unit require arterial cannulation for hemodynamic monitoring and blood sampling. Arterial access is achieved through catheterization of umbilical or peripheral arteries. Peripheral artery cannulation is performed in critically ill newborns, but artery localization and cannulation is often challenging and unsuccessful. Therefore, increasing the internal diameter and preventing vasospasm are important for successful peripheral artery cannulation in neonates. Topical glyceryl trinitrate has the potential to increase cannulation success by relaxing arterial smooth muscles and thus increasing the internal diameter. We aim to conduct a pilot randomized controlled trial to evaluate the efficacy and safety of topycal glyceryl trinitrate in increasing the diameter of the radial artery in neonates. METHODS/DESIGN: This study will be a single-center, observer-blind, randomized, placebo-controlled trial conducted in the neonatal intensive care unit of Perth Children's Hospital, Western Australia. A total of 60 infants born at >34 weeks of gestation who are admitted for elective surgery or medical reasons and for whom a peripheral arterial line is needed for sampling or blood pressure monitoring will be recruited after informed parental consent is obtained. The primary outcome will be the change in radial arterial diameter from baseline to postintervention. Secondary outcomes will be the absolute and percentage change from baseline in the radial arterial diameter in both limbs and safety (hypotension and methemoglobinemia). DISCUSSION: This will be the first randomized controlled trial evaluating the use of topical glyceryl trinitrate to facilitate peripheral artery cannulation in neonates. If our pilot randomized controlled trial confirms the benefits of glyceryl trinitrate patches, it will pave the way for large multicenter randomized controlled trials in this field.
Assuntos
Cateterismo Periférico , Nitroglicerina , Lactente , Criança , Humanos , Recém-Nascido , Nitroglicerina/uso terapêutico , Artéria Radial , Cateterismo Periférico/efeitos adversos , Austrália Ocidental , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
ABSTRACT Background: Newborn infants admitted to the neonatal intensive care unit require arterial cannulation for hemodynamic monitoring and blood sampling. Arterial access is achieved through catheterization of umbilical or peripheral arteries. Peripheral artery cannulation is performed in critically ill newborns, but artery localization and cannulation is often challenging and unsuccessful. Therefore, increasing the internal diameter and preventing vasospasm are important for successful peripheral artery cannulation in neonates. Topical glyceryl trinitrate has the potential to increase cannulation success by relaxing arterial smooth muscles and thus increasing the internal diameter. We aim to conduct a pilot randomized controlled trial to evaluate the efficacy and safety of topycal glyceryl trinitrate in increasing the diameter of the radial artery in neonates. Methods/Design: This study will be a single-center, observer-blind, randomized, placebo-controlled trial conducted in the neonatal intensive care unit of Perth Children's Hospital, Western Australia. A total of 60 infants born at >34 weeks of gestation who are admitted for elective surgery or medical reasons and for whom a peripheral arterial line is needed for sampling or blood pressure monitoring will be recruited after informed parental consent is obtained. The primary outcome will be the change in radial arterial diameter from baseline to postintervention. Secondary outcomes will be the absolute and percentage change from baseline in the radial arterial diameter in both limbs and safety (hypotension and methemoglobinemia). Discussion: This will be the first randomized controlled trial evaluating the use of topical glyceryl trinitrate to facilitate peripheral artery cannulation in neonates. If our pilot randomized controlled trial confirms the benefits of glyceryl trinitrate patches, it will pave the way for large multicenter randomized controlled trials in this field.
RESUMO Histórico: Os recém-nascidos internados na unidade de terapia intensiva neonatal necessitam de canulação arterial para monitoramento hemodinâmico e coleta de sangue. O acesso arterial é obtido por meio de cateterização das artérias umbilicais ou periféricas. A canulação da artéria periférica é realizada em recém-nascidos em estado grave, mas a localização e a canulação da artéria são, muitas vezes, desafiadoras e sem sucesso. Assim, o aumento do diâmetro interno e a prevenção do vasoespasmo são importantes para o sucesso da canulação da artéria periférica em recém-nascidos. O trinitrato de glicerilo tópico tem o potencial de aumentar o sucesso da canulação ao relaxar a musculatura lisa arterial e, dessa forma, aumentar o diâmetro interno. Nosso objetivo é realizar um ensaio piloto controlado e randomizado para avaliar a eficácia e segurança do trinitrato de glicerilo tópico no aumento do diâmetro da artéria radial em recém-nascidos. Métodos/Desenho: Este estudo será um estudo de centro único, cego para o observador, randomizado, controlado por placebo, conduzido na unidade de terapia intensiva neonatal do Perth Children's Hospital, Austrália Ocidental. Serão recrutados 60 bebês nascidos com mais de 34 semanas de gestação, internados para cirurgia eletiva ou por razões médicas e para os quais é necessária a colocação de um acesso arterial periférico para coleta de amostras ou monitoramento da pressão arterial, após a obtenção do consentimento informado dos pais. O desfecho primário será a mudança no diâmetro arterial radial basal e pós-intervenção. Os desfechos secundários serão a alteração absoluta e percentual basal no diâmetro arterial radial em ambos os membros e a segurança (hipotensão e metemoglobinemia). Discussão: Este será o primeiro estudo controlado e randomizado a avaliar o uso de trinitrato de glicerilo tópico para facilitar a canulação da artéria periférica em recém-nascidos. Se nosso estudo-piloto randomizado e controlado confirmar os benefícios dos adesivos de trinitrato de glicerilo, ele abrirá caminho para grandes estudos multicêntricos randomizados e controlados nesse campo.
RESUMO
OBJECTIVE: To evaluate the efficacy and safety of nebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates at high risk of bronchopulmonary dysplasia (BPD). STUDY DESIGN: Single-center, randomized, double-blind, placebo-controlled trial was conducted. Infants of 23(0) to 27(6) weeks' gestational age requiring mechanical ventilation or ≥30% supplemental oxygen on continuous positive airway pressure at 72-168 hours were randomized to receive 20 mg/kg (1 mL/kg) nebulized pentoxifylline or an equal volume of normal saline placebo every 6 hours for 10 consecutive days via a vibrating mesh nebulizer. The primary outcome was the duration of oxygen supplementation at 40 weeks' postmenstrual age. We used Cox proportional hazards regression modeling to analyze outcomes. RESULTS: All infants had adequate data for analysis of the primary outcome. Intention-to-treat analysis revealed no differences in duration of oxygen supplementation at 40 weeks' postmenstrual age between pentoxifylline (n=41) and placebo (n=40) groups (median 2262 vs 2160 hours, adjusted hazard ratio: 1.14, 95% CI 0.72-1.80, P=.63). There was no difference in mortality and further secondary outcomes. No adverse effects were noted. CONCLUSIONS: Nebulized pentoxifylline is safe but did not reduce the duration of oxygen supplementation in extremely preterm infants at high risk of BPD. Dose-ranging studies and large, well-designed clinical trials are required to determine whether the use of nebulized or systemic pentoxifylline as a prophylactic therapy offers small but relevant benefits for prevention of BPD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12611000145909.