Sophia Observation withdrawal Symptoms-Paediatric Delirium scale: A tool for early screening of delirium in the PICU.

BACKGROUND: Delirium in critically ill children is a severe neuropsychiatric disorder which has gained increased attention from clinicians. Early identification of delirium is essential for successful management. The Sophia Observation withdrawal Symptoms-Paediatric Delirium (SOS-PD) scale was developed to detect Paediatric Delirium (PD) at an early stage. OBJECTIVE: The aim of this study was to determine the measurement properties of the PD component of the SOS-PD scale in critically ill children. METHODS: A prospective, observational study was performed in patients aged 3 months or older and admitted for more than 48h. These patients were assessed with the SOS-PD scale three times a day. If the SOS-PD total score was 4 or higher in two consecutive observations, the child psychiatrist was consulted to assess the diagnosis of PD using the Diagnostic and Statistical Manual-IV criteria as the "gold standard". The child psychiatrist was blinded to outcomes of the SOS-PD. The interrater reliability of the SOS-PD between the care-giving nurse and a researcher was calculated with the intraclass correlation coefficient (ICC). RESULTS: A total of 2088 assessments were performed in 146 children (median age 49 months; IQR 13-140). The ICC of 16 paired nurse-researcher observations was 0.90 (95% CI 0.70-0.96). We compared 63 diagnoses of the child psychiatrist versus SOS-PD assessments in 14 patients, in 13 of whom the diagnosis of PD was confirmed. The sensitivity was 96.8% (95% CI 80.4-99.5%) and the specificity was 92.0% (95% CI 59.7-98.9%). CONCLUSIONS: The SOS-PD scale shows promising validity for early screening of PD. Further evidence should be obtained from an international multicentre study.

Nursing protocol violations: detect, correct and communicate.

AIMS AND OBJECTIVES: The Critical Nursing Situation Index (CNSI) is a checklist to detect nursing protocol violations. The objectives of this study were to determine incidences and severities of nursing protocol violations and to check whether corrective actions were taken. DESIGN: Prospective observational audit. METHODS: This study was performed in the Intensive Care Unit of the Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. The CNSI was applied in the period February 2009 to February 2010 by 14 purpose-trained nurses whose interrater reliability had proved sufficient. The checklist addressed nine domains of nursing care: Basic care, Circulation, Respiration, Digestive tract, Infection, Invasive catheters, Medication, ECMO and Central nervous system. The trained nurses also recorded whether violations were discussed with the bedside nurse, whether they could be corrected; and whether they were justifiable. Protocol violations are justifiable when protocol adherence carries greater risk of harm to the patient. RESULTS: Protocol violations were identified for 987 of 8107 items (12·2%) checked in 238 observations in 126 patients. The percentage of protocol violations varied from 5% in the Medication domain to 26% in the Digestive tract domain. More than fifty percent (53·4%) of all protocol violations were corrected in the same shift; 22·3% of all protocol violations proved justifiable, however, these were rarely documented (6·4% of cases). Nurses' classification of the severity of the protocol violations was not reliable because linearly weighted kappa varied from 0 to 0·33. CONCLUSIONS: The CNSI is a useful tool to monitor and correct nursing protocol violations. RELEVANCE TO CLINICAL PRACTICE: Timely identification and correction of protocol violations will reduce possible adverse events resulting from these violations. Furthermore, this study made us aware that protocol violations may be justifiable in clinical practice provided they are well documented.

The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

BACKGROUND: Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. METHODS/DESIGN: This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. DISCUSSION: To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1310.

Efficacy and safety of a parenteral amino acid solution containing alanyl-glutamine versus standard solution in infants: a first-in-man randomized double-blind trial.

BACKGROUND & AIMS: Efforts are directed at reaching the optimal composition of pediatric amino acids (AA) infusions. The goal was to demonstrate the safety and efficacy of a newly developed parenteral AA solution containing alanyl-glutamine (GLN-AA) compared to Standard-AA. METHODS: This is a randomized (2:1), double-blind, multicentre clinical pilot trial. Infants after surgical interventions were allocated to receive GLN-AA or Standard-AA over a minimum of 5 days to maximum of 10 days. AA profiles in blood samples obtained at baseline, day 7, and end of treatment were compared to normal ranges. Data regarding safety, and efficacy were also collected. RESULTS: Infants were comparable for (safety population) gestational age at birth (36 vs 38 weeks), birth weight (2460 vs 2955 g), and day of life during start intervention (1 vs 2 days). Plasma AA profiles in infants treated with GLN-AA (n = 13) were closer the normal ranges than those in infants treated with Standard-AA (n = 6). There were no clinical or statistical differences in adverse events, safety and efficacy parameters between both groups. CONCLUSION: This first-in-man study shows that GLN-AA is safe in infants after surgical interventions, and is well tolerated. Compared to reference values, GLN-AA better reflects the amino acid requirements of the infant.