In laboratory animals, exposure to most general anaesthetics leads to neurotoxicity manifested by neuronal cell death and abnormal behaviour and cognition. Some large human cohort studies have shown ...an association between general anaesthesia at a young age and subsequent neurodevelopmental deficits, but these studies are prone to bias. Others have found no evidence for an association. We aimed to establish whether general anaesthesia in early infancy affects neurodevelopmental outcomes.
In this international, assessor-masked, equivalence, randomised, controlled trial conducted at 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand, we recruited infants of less than 60 weeks' postmenstrual age who were born at more than 26 weeks' gestation and were undergoing inguinal herniorrhaphy, without previous exposure to general anaesthesia or risk factors for neurological injury. Patients were randomly assigned (1:1) by use of a web-based randomisation service to receive either awake-regional anaesthetic or sevoflurane-based general anaesthetic. Anaesthetists were aware of group allocation, but individuals administering the neurodevelopmental assessments were not. Parents were informed of their infants group allocation upon request, but were told to mask this information from assessors. The primary outcome measure was full-scale intelligence quotient (FSIQ) on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III), at 5 years of age. The primary analysis was done on a per-protocol basis, adjusted for gestational age at birth and country, with multiple imputation used to account for missing data. An intention-to-treat analysis was also done. A difference in means of 5 points was predefined as the clinical equivalence margin. This completed trial is registered with ANZCTR, number ACTRN12606000441516, and ClinicalTrials.gov, number NCT00756600.
Between Feb 9, 2007, and Jan 31, 2013, 4023 infants were screened and 722 were randomly allocated: 363 (50%) to the awake-regional anaesthesia group and 359 (50%) to the general anaesthesia group. There were 74 protocol violations in the awake-regional anaesthesia group and two in the general anaesthesia group. Primary outcome data for the per-protocol analysis were obtained from 205 children in the awake-regional anaesthesia group and 242 in the general anaesthesia group. The median duration of general anaesthesia was 54 min (IQR 41–70). The mean FSIQ score was 99·08 (SD 18·35) in the awake-regional anaesthesia group and 98·97 (19·66) in the general anaesthesia group, with a difference in means (awake-regional anaesthesia minus general anaesthesia) of 0·23 (95% CI −2·59 to 3·06), providing strong evidence of equivalence. The results of the intention-to-treat analysis were similar to those of the per-protocol analysis.
Slightly less than 1 h of general anaesthesia in early infancy does not alter neurodevelopmental outcome at age 5 years compared with awake-regional anaesthesia in a predominantly male study population.
US National Institutes of Health, US Food and Drug Administration, Thrasher Research Fund, Australian National Health and Medical Research Council, Health Technologies Assessment–National Institute for Health Research (UK), Australian and New Zealand College of Anaesthetists, Murdoch Children's Research Institute, Canadian Institutes of Health Research, Canadian Anesthesiologists Society, Pfizer Canada, Italian Ministry of Health, Fonds NutsOhra, UK Clinical Research Network, Perth Children's Hospital Foundation, the Stan Perron Charitable Trust, and the Callahan Estate.
Abstract Study Objective To compare the postoperative analgesia of three different concentrations of levobupivacaine for ilioinguinal/iliohypogastric (II/IH) block in children undergoing inguinal ...hernia repair. Design Double-blind, prospective, randomized, controlled trial. Setting Operating room and postoperative recovery area of a university hospital. Patients 73 ASA physical status I and II children, aged one to 6 years, scheduled for outpatient inguinal hernia repair. Interventions Patients were randomized to receive one of three levobupivacaine concentrations: 0.125% (L0.125), 0.25% (L0.25), or 0.375% (L0.375). All patients received standard anesthesia with sevoflurane and II/IH nerve block. Measurements Heart rate (HR), non invasive blood pressure (NIBP), respiratory rate, end-tidal carbon dioxide concentration (ETCO2 ), and oxygen saturation via pulse oximetry (SpO2 ) were monitored during surgery. Postoperative pain scores with CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) and need for rescue analgesia postoperatively were measured and recorded. Main Results 60 patients entered the postoperative observational period. The number of patients who received rescue analgesia was comparable in the three groups. In Group L0.125, mean CHEOPS score was significantly higher, and time to first administration of rescue analgesia was shorter, than in the other two groups ( P < 0.05). Pain scores and time to first administration of rescue analgesia were comparable between Groups L0.25 and L0.375. Conclusions II/IH nerve block using 0.4 mL kg-1 of 0.25% levobupivacaine provided satisfactory postoperative pain relief after inguinal herniorraphy.
Background: Home care support is beneficial for children needing mechanical ventilation, when clinically stable.
Methods: A retrospective analysis was carried out of the long‐term home ventilation ...management of a pediatric population with chronic respiratory failure composed of 20 ventilator‐dependent children categorized according to age, diagnosis and ventilation support. Age groups consisted of 10% under 1 year, 30% between 2 and 5 years, 30% between 6 and 12 years, and 30% older than 12 years. Diagnostic categories included myopathic disorder, n = 5; congenital central hypoventilation syndrome, n = 6; chest wall disorder, n = 5; cystic fibrosis, n = 1; pulmonary hypertension, n = 1; and diaphragmatic paralysis, n = 2.
Results: Sixty‐five percent were ventilated using non‐invasive mode (NIMV): eight with nasal mask, five with full‐face mask, and two children in NIMV also used negative pressure mode; 35% were ventilated using tracheostomy, one of them also used a diaphragmatic pacer. Seventy percent needed nocturnal ventilatory support, (20% 12–18 h, 10% full‐day). A total of 18 children were included in the home care and follow‐up program. Two children died: one because of worsening of his chronic disease and one because of septic shock.
Conclusion: Although home care ventilation is not yet widely diffused, it represents a valid alternative to long hospitalization for children with stable chronic respiratory failure.
This paper describes multiple intraluminal impedance (MII) in 50 children with typical and atypical gastroesophageal reflux (GER) symptoms and discusses the possible clinical significance of ...objective numeric data provided by MII computed analysis. Patients underwent 24-hr pH/MII monitoring. Reflux parameters were analyzed with relation to age and reported symptoms. Nonacidic MII events occurred as frequently as acidic ones. A Pathologic Bolus Exposure Index associated with a normal pH Reflux Index was detected in 26% of our series. Significant correlations were found regarding acid and bolus clearing times and their ratio. We conclude that the low rate of symptom occurrence in the pediatric population represents a limit on MII evaluation. Our study confirmed that nonacid GER is at least as frequent as acid GER. As MII provides interesting objective data that could be used in clinical practice, we suggest further research to define normal ranges in the pediatric population.
Summary
Background: Infants are noted to frequently sleep during spinal anesthesia, with a concomitant fall in Bispectral Index. However, there are suggestions that EEG derived anesthesia depth ...monitors have inferior performance in infants. The aim of this study was to quantify the degree of sedation during spinal anesthesia in infants using another EEG derived measure of anesthesia effect – the Cerebral State Index (CSI).
Methods: Twelve infants, <52 weeks postconceptual menstrual age, scheduled for bilateral inguinal hernia repair under spinal anesthesia were enrolled. Patients received a standard anesthetic protocol with a subarachnoid dose of 1 mg·kg−1 of levobupivacaine 0.5%. No premedication, sedatives, opioids or anticholinergics were administrated during the perioperative period and patients were left undisturbed during the surgical time, without tactile stimulation or loud auditory stimuli. CSI score (0–100) and bust suppression (BS) (0–100%) were continuously recorded during the surgical time and then statistically re‐evaluated.
Results: In all patients the CSI fell during the procedure and there were significant levels of BS recorded by the CSI monitor. The BS occurred between 12 and 34 min after spinal anesthesia with the peak being at 30 min and mean onset time being 15 (2.6) min after spinal block. A statistical significant difference was found between the lowest mean CSI as well as the highest BS if compared with their baseline values. A negative correlation was found between CSI and BS.
Conclusions: The degree of burst suppression detected by the CSI in our study supports the hypothesis that infants may have discontinuous patterns of EEG during spinal anesthesia similar to those seen during emergence from general anesthesia. Moreover, the limitations in the application of the adult algorithms to infant EEG may lead to an overestimation of the degree of sedation.
Summary Background Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an ...increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial. Methods In this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov , number NCT00756600. Findings Between Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as-per-protocol analysis, the cognitive composite score (mean SD) was 98·6 (14·2) in the awake-regional group and 98·2 (14·7) in the general anaesthesia group. There was equivalence in mean between groups (awake-regional minus general anaesthesia 0·169, 95% CI −2·30 to 2·64). The median duration of anaesthesia in the general anaesthesia group was 54 min. Interpretation For this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia. Funding Australia National Health and Medical Research Council (NHMRC), Health Technologies Assessment-National Institute for Health Research UK, National Institutes of Health, Food and Drug Administration, Australian and New Zealand College of Anaesthetists, Murdoch Childrens Research Institute, Canadian Institute of Health Research, Canadian Anesthesiologists' Society, Pfizer Canada, Italian Ministry of Heath, Fonds NutsOhra, and UK Clinical Research Network (UKCRN).
Legionella pneumophila is responsible for hospital or community-acquired pneumonia. Neonatal legionellosis is associated with rapidly severe clinical course and high mortality rates. We describe a ...case of hospital-acquired Legionella pneumonia in a newborn with undiagnosed tracheoesophageal fistula and acute respiratory failure requiring venovenous extracorporeal membrane oxygenation support before fistula repair. Standardized multiplex polymerase chain reaction assay allowed early diagnosis. Extracorporeal life support associated with appropriate antibiotic therapy, surfactant, and steroid therapy was effective in achieving complete recovery. This is the first report of successful neonatal extracorporeal life support for respiratory failure secondary to L pneumophila.
Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study ...is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia.
Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded.
Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio OR, 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature.
RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.
Congenital and acquired airway anomalies represent a relatively common albeit challenging problem in a national tertiary care hospital. In the past, most of these patients were sent to foreign ...Centres because of the lack of local experience in reconstructive surgery of the paediatric airway. In 2009, a dedicated team was established at our Institute. Gaslini's Tracheal Team includes different professionals, namely anaesthetists, intensive care specialists, neonatologists, pulmonologists, radiologists, and ENT, paediatric, and cardiovascular surgeons. The aim of this project was to provide these multidisciplinary patients, at any time, with intensive care, radiological investigations, diagnostic and operative endoscopy, reconstructive surgery, ECMO or cardiopulmonary bypass. Aim of this study is to present the results of the first year of airway reconstructive surgery activity of the Tracheal Team.
Between September 2009 and December 2010, 97 patients were evaluated or treated by our Gaslini Tracheal Team. Most of them were evaluated by both rigid and flexible endoscopy. In this study we included 8 patients who underwent reconstructive surgery of the airways. Four of them were referred to our centre or previously treated surgically or endoscopically without success in other Centres.
Eight patients required 9 surgical procedures on the airway: 4 cricotracheal resections, 2 laryngotracheoplasties, 1 tracheal resection, 1 repair of laryngeal cleft and 1 foreign body removal with cardiopulmonary bypass through anterior tracheal opening. Moreover, in 1 case secondary aortopexy was performed. All patients achieved finally good results, but two of them required two surgeries and most required endoscopic manoeuvres after surgery. The most complex cases were the ones who had already been previously treated.
The treatment of paediatric airway anomalies requires a dedicated multidisciplinary approach and a single tertiary care Centre providing rapid access to endoscopic and surgical manoeuvres on upper and lower airways and the possibility to start immediately cardiopulmonary bypass or ECMO.The preliminary experience of the Tracheal Team shows that good results can be obtained with this multidisciplinary approach in the treatment of complicated cases. The centralization of all the cases in one or few national Centres should be considered.
We report a case of antenatally diagnosed left-sided congenital diaphragmatic hernia, managed on venovenous extracorporeal membrane oxygenation with an hemodynamic and ventilation strategy aimed at ...preventing left and right ventricular dysfunction. Keeping the ductus arteriosus open with prostaglandin infusion and optimizing lung recruitment were effective in achieving hemodynamic stabilization and an ideal systemic oxygen delivery. The patient was discharged from the hospital and had normal development at 1 year of age. The combination of ductal patency and lung recruitment has not been previously reported as a strategy to stabilize congenital diaphragmatic hernia patients undergoing venovenous extracorporeal membrane oxygenation. We believe that this approach may deserve further evaluation in prospective studies.