Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit.

OBJECTIVE: To determine the incidence, type, and stage of occurrence of medication errors and potential and actual adverse drug events (ADEs) in a pediatric intensive care unit (ICU) using trained observers. The preventability and severity of ADEs and the system failures leading to medication error occurrence were also investigated. DESIGN: Prospective, direct observation study. SETTING: A 16-bed pediatric medical/surgical ICU at a tertiary care academic medical center. PATIENTS: One enrolled nurse caring for at least one pediatric ICU patient age <18 yrs was randomly chosen during each observation period. INTERVENTIONS: Observers would intervene only in the event that the medication error would cause substantial patient harm or discomfort. MEASUREMENTS AND MAIN RESULTS: Medication errors and potential and actual ADEs were identified throughout the entire medication use process. The 26 12-hr observation periods included 357 reviewed written orders and 263 observed doses. The study observers identified 58 incidents, which were subsequently classified by the evaluators according to clinical importance, severity, and preventability. Fifty-two of these incidents were considered medication errors; six incidents were determined to be nonpreventable ADEs. Of the 52 medication errors, 42 (81%) were considered clinically important. Potential ADEs comprised 35 (83%) of these important medication errors; the other seven (17%) were classified as actual, preventable ADEs. Overall, the actual and potential ADE rate occurred at 3.6 events and 9.8 events per 100 orders, respectively. CONCLUSIONS: Our medication error rate was similar to that of previous pediatric ICU studies that used the direct observation method for reporting but higher than the rates in previous studies using other detection techniques such as voluntary incident reporting. Periodic direct observation and other ongoing data collection methods such as voluntary incident reporting have the potential to be complementary approaches to medication error and ADE detection.     

Towards safer neonatal transfer: the importance of critical incident review.

BACKGROUND: Critical incidents are common during the inter-hospital transfer of sick patients, and infants are an especially vulnerable group. AIMS: To examine the effect of critical incident review on the number of adverse events during inter-hospital transfer of sick infants. METHODS: Critical incidents over an eight year period are reported from a single neonatal transfer service before and after major service changes were made. The changes were instigated as part of ongoing critical incident reviews. RESULTS: Changes made as a result of critical incident review significantly reduced the number of incidents contributed to by poor preparation, transport equipment or clinical problems, ambulance delays, and ambulance equipment failure. CONCLUSIONS: The continuous process of critical incident reporting and review can reduce the number of adverse events during the transfer of critically ill infants.     

Towards safer neonatal transfer: the importance of critical incident review

Background: Critical incidents are common during the inter-hospital transfer of sick patients, and infants are an especially vulnerable group. Aims: To examine the effect of critical incident review on the number of adverse events during inter-hospital transfer of sick infants. Methods: Critical incidents over an eight year period are reported from a single neonatal transfer service before and after major service changes were made. The changes were instigated as part of ongoing critical incident reviews. Results: Changes made as a result of critical incident review significantly reduced the number of incidents contributed to by poor preparation, transport equipment or clinical problems, ambulance delays, and ambulance equipment failure. Conclusions: The continuous process of critical incident reporting and review can reduce the number of adverse events during the transfer of critically ill infants.     

Critical incident reporting systems

Approximately 10% of all hospital admissions are complicated by critical incidents in which harm is caused to the patient - this amounts to more than 850,000 incidents annually. Critical incident reporting (CIR) systems refer to the structured reporting, collation and analysis of such incidents. This article describes the attributes required for an effective CIR system. Example neonatal trigger events and a management pathway for handling a critical incident report are described. The benefits and limitations of CIR systems, reactive and prospective approaches to the analysis of actual or potential critical incidents and the assessment of risk are also reviewed. Individual human error is but one contributor in the majority of critical incidents. Recognition of this and the fostering of an organisational culture that views critical incident reports as an opportunity to learn and to improve future patient care is vital if CIR systems are to be effective.     

The role of critical incident monitoring in detection and prevention of human breast milk confusions

Feeding a mother’s expressed breast milk to the wrong infant is a well-known misidentification error in neonatal intermediate care units (NICU) with potential harmful consequences for the neonate. In this study, we aimed to analyze the role of critical incident monitoring on detection and prevention of human breast milk confusions. The critical incident monitoring made us aware of this misidentification error on our NICU. Despite the implementation of system changes to make breast milk application clearer and safer, we failed to reduce the incidence of breast milk confusions.     

Cholestasis in neonatal intensive care unit: incidence, aetiology and management

Aim:  Prevalence, aetiology, management and outcome of cholestasis were evaluated in infants admitted to neonatal intensive care unit (NICU).
Methods:  Medical records of all infants admitted to two Italian level III NICUs from January 2005 to August 2007 were retrospectively reviewed. The role of ursodeoxycholic acid (UDCA) therapy was also investigated.
Results:  Twenty-seven of 1289 enrolled infants developed cholestasis. In 25 infants, cholestasis had a multifactorial basis, while in two, no aetiology was found. UDCA did not significantly affect clinical and biochemical course of cholestasis. During a period of 12 months, eight cholestatic infants died, one underwent liver transplantation and 18 fully recovered.
Conclusion:  Infants admitted in NICU have a rate of cholestasis higher than that reported in the general population of live births; in most cases, cholestasis is associated to multiple risk factors and shows a favourable outcome. UDCA does not seem to affect clinical course of cholestasis in this setting.     

Asistencia respiratoria en las unidades de cuidados intensivos neonatales en España: situación en 2005

AimTo learn the characteristic of the neonatal intensive care units (NICUs) that offer neonatal respiratory assistance in Spain.Material and methodA structured survey was developed and sent to all Spanish neonatal units to learn about the respiratory care offered in 2005.ResultsA total of 96 Units answered the survey, with an estimated representatively of 63%, with a range from 3 to 92%, depending on the geographical area. Level IIIc Units were in the upper range. Answer the survey 26 units type IIb (27%), 16 IIIa (17%), 40 IIIb (42%) and 14 IIIc (14%). The total number of level III NICU beds was 541 (1.2 beds per 1000 livebirths; range, 0.7–1.7). The mean number of beds per NICU was 4.1 in level IIIa Units, 2.8 in those IIIb and 14.6 in type IIIc NICUs. In level III NICUs, the bed per physician ratio was 2.4 and that of beds per registered nurse was 2.8 (2.2 in level IIIc NICUs). There were a total 13,219 admissions, 54% of those needed mechanical ventilation (36% in IIIa and 65% in level IIIc NICUs). Oxygen blenders for resuscitation at birth were available in 42% of level IIIb and IIIc NICUs. NICUs had one neonatal ventilator per bed, and 63% of units had high frequency ventilation available. All units had nasal-CPAP systems, 25% of level IIIa Units, 58% IIIb and 64% of those type IIIc had systems for nasal ventilation. All level IIIc and 93% of level IIIb NICUs were able to provide inhaled nitric oxygen therapy. Four NICUS offered ECMO.ConclusionsThe mean number of NICU beds per 1000 livebirths is within the lower limits of those been recommended, and there were wide variations among different geographical areas. A 54% of those babies admitted to NICUs required mechanical ventilation. The mean number of NICU beds per registered nurse was 2.8. There was an adequate number of neonatal ventilators (one per bed) and 63% were able to provide HFV. All NICUs hand n-CPAP systems.     

新生儿重症监护室环境压力对早产儿神经发育的影响及其表观遗传学研究进展

新生儿重症监护室（NICU）的不良环境刺激会通过表观遗传修饰影响神经发育,对早产儿长期发育结局有不良影响,发育支持干预能逆转基因表观遗传改变而促进早产儿神经发育。该文就NICU压力环境、发育支持干预对早产儿神经发育的影响及其表观遗传效应做一综述,为开展早产儿表观遗传学研究提供参考。     

Quality of care of VLBW neonates: relationship between unit volume and outcome is different between metropolitan and rural regions

Abstract Background: Recent studies from predominantly rural areas in Germany show that neonatal outcome of very low birth weight (VLBW) neonates is (on average) inferior with lower NICU (neonatal intensive care unit) volume. However, there are no data available which show that study results of one specific region can be transferred to other areas with possibly different medical infrastructure and needs. Aim: It was investigated whether a systematic difference of treatment quality between smaller (1000-2000 births/year; 3000 births/year; >20 neonatal beds) exists. Furthermore, the results are compared to data from a rural region in order to discuss transferability between regions. Methods: Retrospectively, completely, and for the first time, the data of all centres which treat VLBW neonates (相似文献   

The evidence base for neonatal surgery

The practise of evidence based medicine means integrating the clinical expertise with the best available external clinical evidence from systematic research. There is a lack of supporting scientific evidence from rigorous trials in neonatal surgery. The indications for surgery and the type of operation performed in neonates are rarely supported by randomised controlled trials. As a consequence, the majority of the operations performed in neonates are supported by retrospective studies and surgeon preference.This review article is focussed on operations in neonates which are performed by general paediatric surgeons. Only a few randomised controlled trials have been performed in neonatal diseases such as congenital diaphragmatic hernia, necrotizing enterocolitis, pyloric stenosis and inguinal hernia. All of these trials have been based on collaboration between paediatric surgical units highlighting the importance of creating a network of centres that will promote multicentre prospective studies.     

NOISE POLLUTION IN NEONATAL UNITS: A POTENTIAL HEALTH HAZARD

Abstract. Anagnostakis, D., Petmezakis, J., Messaritakis, J. and Matsaniotis, N. (First Department of Pediatrics of Athens University, Athens, Greece). Noise pollution in neonatal units: a potential health hazard. Acta Paediatr Scand, 69:771, 1980.—Hospital noise levels were measured for four consecutive days every two hours throughout the day in a neonatal intensive care unit (NICU), a normal nursery room and inside infant incubators when the latter were associated with different types of life-support equipment. There was a difference in the noise level between normal nursery and NICU, whereas a considerable increase of noise was recorded when the infant received supplemental oxygen, was under ventilator or when an air compressor was in operation. High noise levels were equally the same both in a.m. and p.m. hours in the NICU. As many high risk infants spend a long time in a NICU, there is an urgent need for further evaluation of noise levels and their effect on the outcome of infants.     

Survey of the definition and screening of neonatal hypoglycaemia in Australia

Objective : To determine the approach to identifying neonatal hypoglycaemia and the definition of neonatal hypoglycaemia used by neonatal paediatricians in Australian Level 3 neonatal intensive care units (NICU).
Methodology : A questionnaire was sent to the 101 neonatal paediatricians in the 22 Level 3 NICU in Australia asking their method of screening for, and definition of, neonatal hypoglycaemia.
Results : Responses were received from 70 neonatal paediatricians, including all 22 directors. A bedside glucose meter is used in 19 of 22 NICU to screen for hypoglycaemia, whilst one NICU uses a glucose analyzer and another NICU uses a visual colour comparison method. One NICU does not screen, but has blood glucose measured in a satellite laboratory. If the screening method suggests hypoglycaemia, 62 of 63 neonatal paediatricians proceed to blood glucose determination in a laboratory, mostly using plasma samples. Based on the laboratory measurement, the definition of neonatal hypoglycaemia ranged from <1.1 to 3.0 mmol/L.
Conclusions : The majority of neonatal paediatricians in Australian NICU screen for neonatal hypoglycaemia using a bedside glucose meter. There is a wide range in the definition of neonatal hypoglycaemia from <1.1 to 3.0mmol/L.     

Gastrostomy feeding in cerebral palsy: a systematic review.

AIMS: To determine benefits and risks for gastrostomy or jejunostomy feeding compared with oral feeding for children with cerebral palsy. METHODS: Systematic review. Search strategy: electronic databases--Cochrane Library, Medline, Embase, Cinahl, Lilacs, databases of theses, grey literature. INCLUDED: relevant systematic reviews, randomised controlled trials, observational studies, case reports. EXCLUDED: non-systematic reviews and qualitative research. PARTICIPANTS: children with cerebral palsy. INTERVENTION: use of gastrostomy or jejunostomy tube to provide nutrition. OUTCOME: evaluated outcome measures included death, growth, gastro-oesophageal reflux, other complications, psychosocial aspects, and caregiver wellbeing. RESULTS: No relevant systematic reviews or randomised controlled trials were found. Two cohort studies, 15 case series, and eight case reports met the inclusion criteria. Eight studies specifically described percutaneous endoscopic gastrostomy as the intervention. Weight gain resulted from gastrostomy feeding in most cases. There was an approximately fourfold increased risk of death reported in one cohort study for the gastrostomy fed children. Many complications were reported, including potential for increased gastro-oesophageal reflux and fluid aspiration into the lungs. CONCLUSIONS: Benefits associated with gastrostomy or jejunostomy feeding are difficult to assess from the available evidence. Risks of gastrostomy, particularly in relation to surgical complications, have been described but the size of the risk could not be quantified. The finding of a higher death rate for children fed by gastrostomy may merely reflect the greater disability of these compared with orally fed children. Lack of available evidence and the substantial risk of bias in observational studies suggests that a well conducted randomised controlled trial of sufficient size will be needed to answer these problems.     

Assessment by a national survey of needs for NICU and intermediate NICU in France]

The setting up of the so-called "decrees on perinatal safety" on October 1998 has been associated with many difficulties which were apparently related to the lack of beds for intensive care units, special care units and neonatal medicine. This led to a national survey. OBJECTIVES: The aim of the survey was : (1) to collect the number of neonates requiring hospitalization in NICU and special care units over a 1-week period in metropolitan France and overseas departments and territories; (2) to assess the needs in equipments and care-givers. METHODS: The writs to be included in the survey were previously identified. Each day of hospitalization was classified as needing an intensive care unit, a special care unit or a neonatal unit. Then it was classified as well fitted or badly fitted. RESULTS: Two hundred and forty units (90% of the French units) from 204 hospitals participated in the survey and 3678 neonates were included and accumulated 17 583 days of hospitalization (NICU: 2728; special care: 5047; neonatal medicine: 9808). One thousand and five hundred and ninety hospitalization days did not fit well either with the technical level required by the neonate or/and with the location of the parents' home (9.2%): 23.1% in overseas departments and territories; 12% in metropolitan France. The main reasons for maladjustment were: a too high technical level: (59%); an insufficient technical level: (21%) (19 neonates could not be admitted in a NICU as they needed). The survey included 158 NICU and special care units. Taking into consideration the French law: the lack in equipment was: 294 ventilators, 231 cardio-respiratory monitors, 116 pulse oxymeters and 513 blood pressure monitors; 561 additional pediatricians were needed to allow a medical night duties including seven doctors in each NICU and each special care unit; 1878 additional nurses were also needed. Making the assumption that the mean occupation rate of the neonatal beds should be 70%, the needs were calculated for 1000 live births: metropolitan France: 0.76 (0.74; 0.78) in NICU; 1.45 (1.43-1.47) in special care units; overseas departments and territories: 2 (1.8-2.5) in NICU; 3.5 (3.2-3.8) in special care units. CONCLUSION: Finally, the main deficit was not related to the number of beds but to the equipment and number of care-givers. The status of overseas departments and territories was particularly worrying.     

Proactive telephone support provided to breastfeeding mothers of preterm infants after discharge: a randomised controlled trial

Aim

The aim was to evaluate the effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants after discharge from neonatal intensive care units (NICU).

Methods

Between March 2013 and December 2015, a randomised controlled trial was conducted at six NICUs across Sweden. At each NICU, a breastfeeding support team recruited, randomised and delivered the support to participating mothers. The intervention group received a daily proactive telephone call up to 14 days after discharge from the support team. The control group could initiate telephone contact themselves. Primary outcome was exclusive breastfeeding eight weeks after discharge. Secondary outcomes were maternal satisfaction with breastfeeding, attachment, quality of life and parental stress.

Results

In total, 493 mothers were randomised, 231 to intervention group and 262 to control group. There were no differences between the groups for exclusive breastfeeding, odds ratio 0.96, 95% CI 0.66–1.38, nor for maternal satisfaction with breastfeeding, attachment or quality of life. The intervention group reported significantly less parental stress than the controls, t = 2.44, 95% CI 0.03–0.23, effect size d = 0.26.

Conclusion

In this trial, proactive telephone support was not associated with increased exclusive breastfeeding prevalence eight weeks following discharge. However, intervention group mothers showed significantly lower parental stress.     

Pitfalls of adverse event reporting in paediatric cardiac intensive care.

AIMS: To evaluate the pitfalls of incident reporting in a complex medical environment. METHODS: Retrospective review of 211 incident reports in a paediatric cardiac intensive care unit (CICU). Two adverse event reporting databases were compared: database A (DA), the hospital's official reporting system, is non-anonymous and reports are predominantly made by nurses; database B (DB) is anonymous and reports are submitted by a CICU consultant who collects data from daily ward rounds. Both databases classify adverse events into incident type (drug errors, ventilation, cannulae/indwelling lines, chest drains, blood transfusion, equipment, operational) and severity (0 = no, 1 = minor, 2 = major, 3 = life threatening consequences). RESULTS: Between 1 April 1998 and 31 July 2001 there were 211 adverse events involving 178 patients (11.87%), among 1500 patients admitted to CICU. A total of 112 incidents were reported in DA, 143 in DB, and 44 in both. In isolation, both databases gave an unrepresentative picture of the true frequency and severity of adverse events. Under-reporting was especially notable for less severe events (grade 0, or near misses) CONCLUSION: Incident reporting in the medical field is highly variable, and is heavily influenced by profession of the reporters as well as anonymity. When adverse event reporting is based predominantly on the observations of a single professional group, the data are grossly inaccurate.     

Management of outbreaks in neonatal intensive care units

Outbreaks in neonatal intensive care units (NICUs) have disastrous consequences for neonates and raise enormous concerns in staff, altering usual practice patterns of the NICU. Our objective was to perform a systematic analysis for gaining insights into the control and prevention of NICUs outbreaks. Epidemiology, risk factors and outcomes are reviewed.     

Prediction of growth and development in intensive care nursery graduates at 12 months of age

Although many perinatal events have been linked with the outcome status of neonatal intensive care unit (NICU) graduates, few studies have evaluated the cumulative longitudinal prediction of outcome. This study followed up 65 term and 139 premature NICU graduates to 12 months' chronologic age. Variables that were utilized in predicting 12-month growth and the neurologic and developmental outcome were maternal and neonatal medical factors, prior growth measurements, and neonatal behavior, which was measured with the Brazelton Scale for term infants and with a modified version for premature infants. The neurologic status was normal in 141 (71.9%) of 204 infants. The average Bayley Scale Mental Developmental Index was 112.7, and the average Psychomotor Developmental Index was 97.5, which was corrected for early gestation. Predictions of 12-month neurologic and developmental status were weak and had been derived only by variables from the neonatal behavioral examination; endurance predicted neurologic status and the motor cluster predicted cognitive and motor development. The prediction of growth at 12 months was high and was derived from prior growth parameters. Thus, although predictions of neurodevelopmental status at 12 months' chronologic age were low, the variables that aided in predicting were from the neonatal behavioral evaluation. This finding provides support for recommending that the functional status of the NICU graduate as well as the more traditional list of perinatal problems be considered when contemplating the infants' short-term outcome.     

Early functional echocardiogram and inhaled nitric oxide: usefulness in managing neonates born following extreme preterm premature rupture of membranes (PPROM)

Aim: Poor neonatal outcome of preterm premature rupture of membranes (PPROM) <24 weeks' gestational age (GA) is probably a result of abnormalities in both airway and vascular developments, ventilation perfusion mismatch, and possibly persistent pulmonary hypertension of the newborn (PPHN). Perinatal mortality of 50–90% has been reported in the past, with recent literature reporting significant improvement in neonatal survival. We report our 8‐year experience in this group of infants using early diagnostic functional echocardiography (fECHO), high‐frequency ventilation (HFV) and inhaled nitric oxide (iNO). Methods: The obstetric and neonatal databases were searched to identify babies with PPROM (<20 weeks' gestation) or rupture earlier than 25 weeks for more than 14 days. Results: Twenty‐six infants were identified, of whom 20 were admitted to the neonatal intensive care unit (NICU; mean GA 27.8 weeks, mean birth weight (BW) 1207 g). Early echocardiographic data were available in 12/15 infants requiring mechanical ventilation of whom 10 had evidence of PPHN. All infants who received iNO therapy survived to discharge and only two infants died. Survival to discharge was 69% for the whole cohort of infants and 90% for infants admitted to the NICU. In contrast, for the cohort from pre‐iNO and ‐HFV era, the overall survival to discharge was 62% and 66% for the infants admitted to the NICU. Conclusion: Premature infants with PPROM and presumed severe hypoxemic respiratory failure because of hypoplastic lungs often have significant PPHN and may show improvement in oxygenation after treatment with HFV and iNO. Early fECHO results in earlier identification and treatment of infants with PPHN in this high‐risk group.