Impact of pharmaceutical validation on prescribing errors in a neonatal intensive care unit. Randomised and controlled study.

Purpose: To compare the frequency of electronic prescription errors when the prescription was validated by the clinical pharmacist vs. when it was not. Methods: This prospective randomised controlled study was conducted in three phases. A randomised phase, in which patients were divided into control and intervention groups, and a pre- and post-intervention phase were consecutively performed to analyse the impact of pharmaceutical validation of prescriptions in a neonatal intensive care unit (NICU). This study was performed at a highly complex NICU at a tertiary hospital. All patients born during the study period who were admitted to the NICU, with a stay lasting ≥24 h, and received active pharmacological treatment were included in the study. Pharmaceutical validation was performed according to the paediatric pharmaceutical care model. A high level of validation was selected for this study. In the intervention group, discrepancies found during the review process were communicated to the medical team responsible for the patients and resolved on the same day. Results: In total, 240 patients were included in this study. Sixty-two patients were allocated to the pre-intervention (n = 38) or post-intervention (n = 24) groups, and 178 patients were randomly sorted into two groups, control (n = 82 newborns) and intervention (n = 96 newborns). During the randomisation phase, the number of prescription errors detected was significantly lower in the intervention group than that in the control group (129 vs. 270; p < 0.001). Similarly, prescription errors reaching the patient were significantly reduced from 40% (n = 108) in the control group to 1.6% (n = 2) in the intervention group. In the pre- and post-intervention periods, the prescription lines containing prescription errors decreased from 3.4% to 1.5% (p = 0.005). Conclusions: This study showed that the pharmaceutical validation process decreased both the number of errors in the electronic prescribing tools and the number of prescription errors reaching the patient.

Metataxonomic Analysis of Milk Samples From SARS-CoV-2-Positive and SARS-CoV-2-Negative Women.

Objective: To assess the impact of SARS-CoV-2 viral infection on the metataxonomic profile and its evolution during the first month of lactation. Methods: Milk samples from 37 women with full-term pregnancies and mild SARS-CoV-2 infection and from 63 controls, collected in the first and fifth postpartum weeks, have been analyzed. SARS-CoV-2 RNA was assessed by reverse transcription polymerase chain reaction (RT-PCR) both in cases and controls. After DNA extraction, the V3-V4 hypervariable region of the gene 16S rRNA was amplified and sequenced using the MiSeq system of Illumina. Data were submitted for statistical and bioinformatics analyses after quality control. Results: All the 1st week and 5th week postpartum milk samples were negative for SARS-CoV-2 RNA. Alpha diversity showed no differences between milk samples from the study and control group, and this condition was maintained along the observation time. Analysis of the beta-diversity also indicated that the study and control groups did not show distinct bacterial profiles. Staphyloccus and Streptococcus were the most abundant genera and the only ones that were detected in all the milk samples provided. Disease state (symptomatic or asymptomatic infection) did not affect the metataxonomic profile in breast milk. Conclusion: These results support that in the non-severe SARS-CoV-2 pregnant woman infection the structure of the bacterial population is preserved and does not negatively impact on the human milk microbiota.

Immediate Pre-Partum SARS-CoV-2 Status and Immune Profiling of Breastmilk: A Case-Control Study.

Objetive: To address the prevalence of SARS-CoV-2 and the evolutionary profile of immune compounds in breastmilk of positive mothers according to time and disease state. Methods: Forty-five women with term pregnancies with confirmed non-severe SARS-CoV-2 infection (case group), and 96 SARS-CoV-2 negative women in identical conditions (control group) were approached, using consecutive sample. Weekly (1st to 5th week postpartum) reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal swabs (cases) and breastmilk (cases and controls) were obtained. Concentration of cytokines, chemokines, and growth factors in breastmilk (cases and controls) were determined at 1st and 5th week post-partum. Results: Thirty-seven (study group) and 45 (control group) women were enrolled. Symptomatic infection occurred in 56.8% of women in the study group (48% fever, 48% anosmia, 43% cough). SARS-CoV-2 RNA was not found in breastmilk samples. Concentrations of cytokines (IFN-γ, IL-1ra, IL-4, IL-6, IL-9, IL-13, and TNF-α) chemokines (eotaxin, IP-10, MIP-1α, and RANTES) and growth factors (FGF, GM-CSF, IL7, and PDGF-BB) were higher in breastmilk of the study compared with the control group at 1st week postpartum. Immune compounds concentrations decreased on time, particularly in the control group milk samples. Time of nasopharyngeal swab to become negative influenced the immune compound concentration pattern. Severity of disease (symptomatic or asymptomatic infection) did not affect the immunological profile in breast milk. Conclusions: This study confirms no viral RNA and a distinct immunological profile in breastmilk according to mother's SARS-CoV-2 status. Additional studies should address whether these findings indicate efficient reaction against SARS-CoV-2 infection, which might be suitable to protect the recipient child.

[Recommendations for respiratory support in the newborn (iii). Surfactant and nitric oxide]. / Recomendaciones para la asistencia respiratoria en el recién nacido (iii). Surfactante y óxido nítrico.

The recommendations included in this document will be part a series of updated reviews of the literature on respiratory support in the newborn infant. These recommendations are structured into twelve modules, and in this work module 7 is presented. Each module is the result of a consensus process including all members of the Surfactant and Respiratory Group of the Spanish Society of Neonatology. They represent a summary of the published papers on each specific topic, and of the clinical experience of each one of the members of the group.

[Magnetic resonance imaging without sedation in neonates]. / Resonancia magnética sin sedación en recién nacidos.

INTRODUCTION: The ability to perform magnetic resonance imaging (MRI) without sedation in the neonatal period increases patient safety, availability and profitability of the diagnostic tool. The aim in this study was to evaluate a new protocol of MRI without sedation during a 20-month period. In the protocol, the patients are prepared in the neonatal unit. PATIENTS AND METHOD: Prospective descriptive study, from May 2012 to December 2013. Patients included were neonates requiring MRI, clinically stable and not requiring ventilatory support. The method was based on the application of developmental centered care and the use of a vacuum matress to immobilize the baby. The principal outcome parameter of interest was the percentage of succesfully completed MRIs. The duration of the MRI and the number of interruptions, was also studied from October 2012. RESULTS: A total of 43 MRIs without sedation were carried out on 42 patients: 41 cerebral and 2 spinal. The success rate was 97.7% (42/43). The mean MRI time was 26.3 minutes (95% CI 23.3-29.3 mins; range 16-50 mins). MRIs were completed without interruption in 20 of the 34 cases (58%) in which the duration was recorded. The number of interruptions per procedure varied from 0 to 3, with a mean of 0.6 (95% CI 0.3-0.8) and a median of 0. CONCLUSION: The protocol had a success rate of over 90%. Thus MRI without sedation seems applicable in Spanish hospitals, with most of the preparation being performed in the neonatal unit, in order to reduce the occupation of the MRI unit, as well as minimizing stress to the baby.

[Incidence of unplanned extubations in a neonatal intensive care unit. A before and after study]. / Frecuencia de extubaciones no programadas en una unidad de cuidados intensivos neonatales. Estudio antes y después.

INTRODUCTION: Unplanned extubations (UE) of mechanically ventilated newborns involves an undesirable increase in morbidity and mortality. OBJECTIVE: A 2-stage study compared the frequency of UE in a Neonatal Intensive Care Unit before and after the implementation of a program of preventive measures to decrease UE. PATIENTS AND METHODS: A before and after prospective study included all mechanically ventilated newborns participating in the 2 stage study from May-December 2011 and June-December 2012. In stage 1, the rate of UE per 100 intubated patient days was calculated and the characteristics of unplanned extubated newborns, circumstances of UE occurrence and need for re-intubation were studied. Consequently, a program of preventive measures for UE was designed and implemented, with the same variables being analysed in stage 2. RESULTS: No differences were found in patient characteristics during the two stages. Stage 1, incidence of UE was 5/100 intubated patient days; Stage 2, 4.5 UE/100 intubated patient days (P=.657). In both stages, most UE occurred during patient handling with re-intubation incidence at 77.4% and 67.7%, respectively. The combined rate of both stages during summer months of July, August and September was 6.2 UE/100 intubation days, in contrast with the remaining months of both stages: UE incidence rate, 3.4 UE/100 intubation days (p=.043). CONCLUSIONS: The implementation of a preventive measures program did not significantly reduce the incidence of UE. The summer period showed the highest incidence of UE.

Pain and stress assessment after retinopathy of prematurity screening examination: indirect ophthalmoscopy versus digital retinal imaging.

BACKGROUND: Increasingly, neonatal clinics seek to minimize painful experiences and stress for premature infants. Fundoscopy performed with a binocular indirect ophthalmoscope is the reference examination technique for screening of retinopathy of prematurity (ROP), and it is associated with pain and stress. Wide-field digital retinal imaging is a recent technique that should be evaluated for minimizing infant pain and stress. METHODS: The purpose of the study was to assess and compare the impact of using a binocular indirect ophthalmoscope (BIO), or wide-field digital retinal imaging (WFDRI) on pain and stress in infants undergoing ROP screening examination. This was a comparative evaluation study of two screening procedures. Ophthalmologic examinations (N = 70) were performed on 24 infants with both BIO and WFDRI. Pain assessments were performed with two specific neonatal scales (Crying, requires oxygen, increased vital signs, expression and sleeplessness, CRIES and, Premature infant pain profile, PIPP) just prior to the examination, and 30 seconds, 1 hour, and 24 hours later after ending the examination. RESULTS: Changes over time were significantly different between BIO and WFDRI with both scales (PIPP score, p = .007, and CRIES score, p = .001). Median PIPP score (interquartile interval) at baseline was 4 (3-5). At 30 seconds the score was 8 (6-9) for BIO and 6 (5-7) for WFDRI, respectively. The increase in PIPP score between baseline and 30 seconds was significantly lower with WFDRI (p = .006). The median increase in CRIES score from baseline to 30 seconds was 1 point lower for WFDRI than for BIO (p < .001). No significant difference in response remained at 1 hour or 24 hour assessments. CONCLUSIONS: A transient short-term pain and stress response occurs with both BIO and WFDRI. Infants examined for screening of ROP with digital retinal imaging present less pain and stress at 30 seconds following completion of the exam when compared with binocular indirect ophthalmoscopy.

Age of sitting unsupported and independent walking in very low birth weight preterm infants with normal motor development at 2 years.

AIMS: The aims of this study is to (i) determine the age of sitting unsupported and independent walking in preterm infants with birth weight under 1500 g (very low birth weight, VLBW); (ii) estimate differences between VLBW children and a reference population and (iii) estimate the association between clinical characteristics and late age at sitting and walking. METHODS: A longitudinal study was conducted of a cohort of 876 children with VLBW. The World Health Organization (WHO) motor development study population was used as a reference. Ages for both skills were established by interview with parents. Means were compared with t-test, ANOVA and Bonferroni adjustment where appropriate. RESULTS: The inclusion criteria were complied with 694 patients; 50% of VLBW sat at 7 m corrected age (CA) and walked at 13 m CA. Both motor skills were acquired later (7.3 +/- 1.5 and 13.6 +/- 2.8 m) compared with the control group (6 +/- 1.1 and 12.1 +/- 1.8 m). Weight or head circumference at birth below the 10th percentile or the presence of bronchopulmonary dysplasia were associated with delayed acquisition of both skills. CONCLUSION: Very low birth weight infants typically sit unsupported and walk later than term infants. Tables describing reference values for milestones acquisition for different categories of infants (gestational age, birth weight and other determinants) may contribute to inform the decision making process on access to available resources.

Estudio de la calidad de las prescripciones médicas en un servicio de urgencias pediátricas / Study on the quality of the medical prescriptions in a Pediatrics Emergency Service

Antecedentes: En los últimos años se han publicado algunos trabajos sobre el error médico. Los servicios de urgencias pediátricas (SUP) son especialmente susceptibles al error de prescripción, pero se han escrito pocos artículos específicos al respecto. Objetivos: Determinar la frecuencia y las variables asociadas con las desviaciones de la buena práctica médica en las prescripciones médicas en nuestro SUP. Métodos: Estudio retrospectivo observacional. Revisamos las prescripciones realizadas en 58 días elegidos de forma aleatoria (entre julio de 2003 y marzo de 2004). De cada una de ellas evaluamos la legibilidad, el cálculo de dosis, las unidades, el intervalo y la alergia medicamentosa. Recogimos el día de la semana, el turno y el grado de formación del médico responsable. Resultados: Durante los 58 días revisados se realizaron3.143 prescripciones. Detectamos una o más desviaciones de la buena práctica médica en 1.348 (43%). Ninguna de ellas fue clasificada como grave. La variable donde más desviaciones detectamos fue en la legibilidad, seguida del cálculo de la dosis. En el 11%, al menos uno de los elementos se consideró ilegible. Se encontraron diferencias estadísticamente significativas al analizar las variables correspondientes al día de la semana (fin de semana frente a lunes-viernes; p= 0,0036) y el grado de formación (residente frente a adjunto; p <0,0001). Conclusiones: Los errores en la prescripción médica son frecuentes en nuestro SUP; ninguno de ellos es grave, pero sí limitan el buen cumplimiento del tratamiento. Se pueden identificar circunstancias que hacen más frecuentes las desviaciones y, de esta forma, diseñar intervenciones para mejorar la calidad asistencial (AU)

Background: Several papers related to the medical mistakes have been published over the past years. The Pediatrics Emergency Services are specially susceptible as regards to the prescription mistake but there are few specific articles. Objectives: To determine the frequency and variables associated to the deviations of good medical practice in medical prescriptions in our Pediatrics Emergency Service. Methods: Retrospective observational study. We revised the prescriptions done during fifty eight days on a random basis(from July 2003 to March 2004). From every prescription: legibility, dose assessment, units, intervals and drug allergies were evaluated. The day of the week, shift and level of training of the prescribing physician were documented. Results: During the revised 58 day, 3,143 prescriptions were made. One or more deviations to the good medical practice were detected in 1,348 (43%) of the prescriptions. None of the mistakes were classified as severe. The variable where more deviations were detected was the legibility and dosage assessment. In 11% at least one of the elements were considered illegible. Statistical significant differences were found when analyzing the day of the week variables (week-end vs. Monday-Friday, p= 0.0036) and to the level of training (resident vs. pediatricians, p <0.0001). Conclusions: Medical prescription mistakes are very common in our Pediatrics Emergency Service. None of them were severe but limited the good compliance of the treatment. Some characteristics that make deviations more frequent can be identified in order to design interventions to improve the quality (AU)

[Retinopathy of prematurity screening in Spanish neonatal units]. / Cribado de la retinopatía de la prematuridad en las unidades neonatales españolas.

INTRODUCTION: A wide variety of retinopathy of prematurity (ROP) screening criteria exists in the different hospitals. In 1988, the benefits of cryotherapy treatment in severe ROP cases were demonstrated, and since then, some scientific societies have made recommendations on the screening and treatment of ROP. Within the Spanish scientific community, there are no specific recommendations on screening, diagnosis or treatment. OBJECTIVES: To describe the criteria used in the screening of retinopathy in premature newborns by those Spanish hospitals caring for babies with birth weights below 1,500 g. MATERIAL AND METHOD: A cross-sectional study was performed based on a 50 question questionnaire on screening criteria and other related issues. This questionnaire was sent to those public and private neonatal units in Spain caring for babies with birth weights below 1,500 grams. The questionnaire was sent and returned between January 2002 and May 2003. RESULTS: Units in all of the 17 autonomous communities and both autonomous cities in territorial Spain (Ceuta and Melilla) responded. There was a 90% response rate. All the participating hospitals perform ROP screening. Only 62.9% of the hospitals follow a written protocol on screening. A large majority of hospitals (79.8%) perform a retinal eye examination on all newborns below 1500 g at birth. Half of the hospitals included in the study, 51.6%, determine the cut-off point for performing the screening at 32 weeks of gestational age. Around 73% of the hospitals include the administering of oxygen supplements to premature babies as part of the criteria for screening, regardless of the babies' weight and gestational age. Weight, gestational age and oxygen are the only criteria used in 51% of the units. That all hospitals in Spain should establish some screening criteria was suggested by 90% of the responses. Only 10% use analgesia or sedation, other than topical, when examining the retina. CONCLUSIONS: Even though all the hospitals participating in the study screen for ROP, there is little agreement on which criteria should be followed when screening and on other aspects related to its practice.

Factores determinantes de la elevación de la uremia en los primeros días de vida en recién nacidos con menos de 30 semanas de gestación / Determinants of uremia elevation in the first days of life in premature infants born at less than 30 weeks of gestation

Objetivo: Encontrar los determinantes asociados con elevación de la uremia en los primeros días de vida en prematuros muy inmaduros. Métodos: Estudio prospectivo de una cohorte de recién nacidos con menos de 30 semanas de gestación. Resultados: Se incluyeron 48 prematuros nacidos vivos, de los que 10 fallecieron. Los aportes medios de líquidos fueron 55, 72, 88 y 124 ml/kg en el primer, segundo, tercer y séptimo días de vida. El aporte de aminoácidos en los primeros 2 días fue escaso y no se relacionó con la uremia. El 31 por ciento presentaron hipernatremia. En 31 prematuros se obtuvo la uremia entre el quinto y el décimo día de vida. Se encontraron 12 (38,7 por ciento) con valores de 100 mg/dl o superiores, sin elevación de la creatininemia. Todos ellos tuvieron menos de 27 semanas de gestación, menos de 850 g al nacer, mayor pérdida de peso (19,2 por ciento frente a 13,8 por ciento; p = 0,037) y mayor natremia máxima (150,2 mEq/l frente a 146,6 mEq/l; p = 0,023). El uso de furosemida aumentó el riesgo de uremia elevada (riesgo relativo [RR], 2,54; intervalo de confianza del 95 por ciento [IC 95 por ciento], 1,05-6,14).Conclusiones La uremia total de 100 mg/dl o superior se relacionó con determinantes asociados con excesiva pérdida precoz de agua libre, como mayor pérdida de peso, mayor natremia máxima, uso de furosemida, menor gestación y menor peso al nacer (AU)

[Determinants of uremia elevation in the first days of life in premature infants born before 30 weeks of gestation]. / Factores determinantes de la elevación de la uremia en los primeros días de vida en recién nacidos con menos de 30 semanas de gestación.

OBJECTIVE: To identify the determinants associated with uremia elevation in the first days of life in extremely premature infants. METHODS: We performed a prospective cohort study in a cohort of neonates born at less than 30 weeks of gestation. RESULTS: Forty-eight preterm infants were included, of which 10 died. The mean fluid administration was 55, 72, 88 and 124 mL/kg on the first, second, third and seventh days of life. Amino acid doses were low in the first two days of life and were unrelated to uremia elevation. Thirty-one percent of the infants presented hypernatremia. Uremia was measured in 31 infants between the fifth and tenth days of life and 12 infants (38.7 %) had uremia values of 100 mg/dL or higher, without creatinine elevation. All of these infants were born at less than 27 weeks of gestation, weighed less than 850 grams at birth, and showed greater weight loss (19.2 % vs. 13.8 %; p 5 0.037) and higher natremia (150.2 mEq/L vs. 146.6 mEq/L; p 5 0.023). The use of furosemide increased the risk of elevated uremia (relative risk: 2.54; 95 % confidence interval: 1.05 6.14). CONCLUSIONS: Total uremia of 100 mg/dL or higher was associated with dehydration, greater weight loss, higher natremia, furosemide use, lower gestational age, and lower birth weight.

[Medication errors in a neonatal unit]. / Errores en las prescripciones médicas en una unidad neonatal.

INTRODUCTION: Medication errors occur as a result of human mistakes or system flaws and could be prevented by studying and modifying the conditions that predispose to errors. In recent years, interest in medical errors has increased because of their health and economic implications. OBJECTIVES: To evaluate the frequency and types of prescribing errors in the Neonatology Unit of the Hospital 12 Octubre before and after an intervention to raise awareness of errors among the medical staff by comparing the frequency of error before and after the intervention. PATIENTS AND METHODS: We conducted a prospective pilot study in two phases. In the first phase, we studied prescribing errors by reviewing 100 prescriptions for newborns admitted to the Intensive or Intermediate Care Units. When the prescriptions were written, the neonatologists were unaware that the study would be performed. Legibility, dose, units used to express medications, route of administration, use of abbreviations, specification of dosage per kilogram of body weight and use of brand names were evaluated. The information was analyzed and an information-training intervention was performed in which the results were made known in a clinical session and recommendations for improving prescriptions were made. In the second phase, another 100 prescriptions were reviewed. The results were compared with those obtained before the intervention using the chi-squared test. RESULTS: In the first phase, 22 % of prescriptions were illegible or doubtful, 4 % contained dose errors and 28 % did not specify the route of administration. After the intervention, 8 % (p 0.005) of prescriptions were illegible, 4 % contained dose errors and 5 % (p 0.0001) did not specify the route of administration. Regarding other quality markers, the percentage of prescriptions specifying dosage per kilogram of body weight increased from 46 % to 78 %. Brand names were used in 21 %. Units were always expressed in abbreviations. All errors were severity index 0 or 1. CONCLUSIONS: The first step in prevention is recognition of mistakes. Increasing awareness among the medical staff of the consequences of errors improved the quality of prescriptions in our department. Awareness of the frequency and type of errors is the first step towards implementing strategies to reduce iatrogeny.