RESUMEN
OBJECTIVE: To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation. STUDY DESIGN: In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well. RESULTS: Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were >6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P < .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively). CONCLUSION: In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone.
Asunto(s)
Analgésicos Opioides/administración & dosificación , Fentanilo/administración & dosificación , Enfermedades del Prematuro/terapia , Dolor/tratamiento farmacológico , Respiración Artificial/efectos adversos , Insuficiencia Respiratoria/terapia , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/uso terapéutico , Método Doble Ciego , Femenino , Fentanilo/efectos adversos , Fentanilo/uso terapéutico , Estudios de Seguimiento , Humanos , Recién Nacido , Recien Nacido Prematuro , Infusiones Intravenosas , Inyecciones Intravenosas , Modelos Logísticos , Masculino , Dolor/etiología , Dimensión del Dolor , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the pattern of acid and nonacid gastroesophageal reflux (GER) in different body positions in preterm infants with reflux symptoms by a combined multichannel intraluminal impedance (MII)-pH monitoring, which identifies both acid and nonacid GER. STUDY DESIGN: Premature infants with frequent regurgitation and postprandial desaturation (n = 22) underwent a 24-hour recording of MII-pH. In a within-subjects design, reflux indexes were analyzed with the infants in 4 different positions: supine (S), prone (P), on the right side (RS), and on the left side (LS). RESULTS: All infants were analyzed for 20 hours. The mean number of recorded GER episodes was 109.7. The mean esophageal exposure to acid and nonacid GER was lower in positions P (4.4% and 0.3%, respectively) and LS (7.5% and 0.7%, respectively) than in positions RS (21.4% and 1.2%, respectively) and S (17.6% and 1.3%, respectively). The number of postprandial nonacid GER episodes decreased but the number of acid GER episodes increased over time. The LS position showed the lowest esophageal acid exposure (0.8%) in the early postprandial period, and the P position showed the lowest esophageal acid exposure (5.1%) in the late postprandial period. CONCLUSION: Placing premature infants in the prone or left lateral position in the postprandial period is a simple intervention to limit GER.
Asunto(s)
Reflujo Gastroesofágico/terapia , Enfermedades del Prematuro/terapia , Monitoreo Fisiológico/métodos , Postura , Impedancia Eléctrica , Esófago/fisiología , Femenino , Reflujo Gastroesofágico/diagnóstico , Reflujo Gastroesofágico/fisiopatología , Humanos , Concentración de Iones de Hidrógeno , Lactante , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/diagnóstico , Enfermedades del Prematuro/fisiopatología , Masculino , Periodo Posprandial , Postura/fisiologíaRESUMEN
OBJECTIVE: To report the accuracy of ultrasound scanning (US) in predicting neurodevelopmental and sensorineural outcome in patients with congenital cytomegalovirus (CMV) infection. STUDY DESIGN: Fifty-seven neonates with congenital CMV infection underwent brain US and were observed prospectively for motor skills, developmental quotient, and hearing function. RESULTS: Abnormal results on US were found in 12 of 57 neonates. US lesions were more frequent in newborns with clinical and laboratory signs of congenital CMV infection at birth (10/18) than in newborns who had no symptoms at birth (2/39; P < .001). At least 1 sequela developed in all neonates with symptoms who had abnormal US results, whereas none of the neonates with symptoms who had normal US results had long-term sequelae (P < .001). In the population without symptoms, sensorineural hearing loss developed in 3 of 37 (8.1%) neonates with normal US results, whereas severe sequelae developed in 1 of 2 neonates with abnormal US results. CONCLUSIONS: A good correlation was found between cerebral US abnormalities and the prediction of outcome in newborns who were congenitally infected with CMV and had symptoms at birth. US could be performed as the first neuroimaging study in these newborns. Data are insufficient to permit any suggestions for the population without symptoms.