Stability of individualized neonatal parenteral nutrition admixtures with fish oil and high calcium content.

INTRODUCTION: the stability of total parenteral nutrition admixtures for neonates (TPNAn) has been questioned in relation to the interaction between calcium and fish oil emulsions. AIM: the aim of this study was to check the stability (particle size < 1 µm) of different individualized TPNAn prepared with fish-oil emulsion and containing calcium at concentrations ranging from 10 to 20 mmol/L. METHODS: admixtures analyzed: twelve different formulations with SMOFlipid® 20 % (conserved for 24 h and for 96 h), three formulations with Lipoplus® 20 % (conserved for 96 h) and three formulations with SMOFlipid® 20 % with Multi-12K1® Pediatric (conserved for 96 h). Two bags were compounded for each formulation and conservation period. Measurements on each admixture bag: particle standardized diameter by laser diffraction technique and pH by a calibrated pH-meter. Data analysis with mixed linear regression models. RESULTS: maximum particle size was < 0.8 µm for all investigated admixtures. Lipid concentration of 5 g/L and sodium and potassium concentration of 100 mmol/L slightly increased the proportion of particles > 0.6 µm. Ninety six hours storage also increased the percentage of particles > 0.6 µm (+0.143 ± 0.07; p = 0.038) but did not influence other parameters. No association with calcium composition was observed. Amino acid content was inversely correlated with pH (-0.83; p < 0.0001). CONCLUSIONS: the studied individualized parenteral nutrition admixtures for newborns that contain fish oil emulsions and meet cation requirements are stable for at least 96 hours.

Architectural design, facilities and family participation in neonatal units in Spain: A multicentre study.

AIM: The architecture of neonatal units plays a key role in developmental strategies and preterm outcomes. The aim was to evaluate the design of Spanish neonatal units and its impact on the participation of parents in neonatal care. METHODS: A web-based survey was sent to all level III Spanish neonatal units, including questions about hospital data, architectural design, facilities and family participation. RESULTS: The study included 63 units. Most units (87%) had part or all the intensive care patients located in open bay units, while 54% had at least one individual patient cubicle. Single family rooms, defined as those including enough space and furniture for family members to stay with the infant without restrictions, were available in 8 units (13%). Eighteen units (29%) had a structured programme of family education. Units with single family rooms were more likely to have parental participation in rounds (p < 0.01), safety protocols (p = 0.02), oxygen management (p < 0.01) and nasogastric tube feeding (p = 0.02), as well as to allow siblings to participate in kangaroo care (p < 0.01). CONCLUSION: Widely variable architectural designs and policies were found in Spanish neonatal units. The presence of single family rooms may have impacted the participation of parents in neonatal care.

Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study.

INTRODUCTION: Heart transplant (HT) survival has barely improved in the last decades, which is unsatisfactory for many HT recipients. The development of anti-human leukocyte antigen (anti-HLA) antibodies in HT patients is associated with a cardiac allograft dysfunction. The mechanisms leading to this damage are unclear. The Multimodality Evaluation Of Antibody-Mediated Injury In Heart Transplantation (LEONE-HT) study aimed to thoroughly describe the damage inflicted on the myocardium by anti-HLA antibodies. METHODS AND ANALYSIS: The LEONE-HT study is a cohort study with a cross-sectional approach in which HT patients with positive anti-HLA antibodies are compared with coetaneous HT patients with negative anti-HLA antibodies. All patients will undergo a state-of-the-art multimodal assessment, including imaging techniques, coronary anatomy and physiology evaluations and histological and immunological analyses. The individual and combined primary outcomes of structural graft injuries and longitudinal secondary outcomes are to be compared between the exposed and non-exposed groups with univariate and multivariable descriptive analyses. ETHICS AND DISSEMINATION: The LEONE-HT study is carried out in accordance with the principles set out in the Declaration of Helsinki and the International Conference on Harmonization guidelines for good clinical practice and following national laws and regulations. The study design, objectives and participant centers have been communicated to clinicaltrials.gov (NCT05184426). The LEONE-HT study counts on the support of patient associations to disseminate the objectives and results of the research. This study was funded by the Spanish Ministry of Science and Innovation and the Spanish Society of Cardiology.

Maternal and Neonatal Prognostic Factors for Cardiorespiratory Events in Healthy Term Neonates During Early Skin-to-Skin Contact.

Background: During early skin-to-skin contact (ESSC), alterations in peripheral oxygen saturation (SpO2) and heart rate (HR) have been frequently observed. Objectives: This study aimed to determine the incidence of cardiorespiratory events (CREs) during ESSC in healthy term newborns (HTNs) and estimate the association of maternal and neonatal prognostic factors with the risk of CREs. Methods: A pooled analysis of the cohort from a clinical trial involving healthy mother-child dyads during ESSC was performed. Pulse oximetry was employed to continuously monitor SpO2 and HR within 2 h after birth. The individual and combined prognostic relevance of the demographic and clinical characteristics of dyads for the occurrence of a CRE (SpO2 <91% or HR <111 or >180 bpm) was analyzed through logistic regression models. Results: Of the 254 children assessed, 169 [66.5%; 95% confidence interval (95% CI), 60.5-72.5%] had at least one CRE. The characteristics that increased the risk of CRE were maternal age ≥35 years (odds ratio, 2.21; 95% CI, 1.19-4.09), primiparity (1.96; 1.03-3.72), gestational body mass index (BMI) >25 kg/m2 (1.92; 1.05-3.53), and birth time between 09:00 p.m. and 08:59 a.m. (2.47; 1.02-5.97). Conclusion: CREs were more frequent in HTNs born during nighttime and in HTNs born to first-time mothers, mothers ≥35 years, and mothers with a gestational BMI >25 kg/m2. These predictor variables can be determined during childbirth. Identification of neonates at higher risk of developing CREs would allow for closer surveillance during ESSC.

Reducing Early Antibiotic Use: A Quality Improvement Initiative in a Level III Neonatal Intensive Care Unit.

Antibiotic burden is a critical issue in neonatal intensive care units (NICU) and antibiotic use is considered a quality indicator of neonatal care. Our aim was to optimize antibiotic use through a quality improvement (QI) initiative that included revision of departmental protocols and implementation of a surveillance system based on process indicators. Methods: This is descriptive study of a cohort of all very low birth weight (VLBW) infants admitted to the NICU from 2014 to 2019. A series of QI interventions were made during the study period and included departmental protocols and the implementation of a surveillance system based on process indicators. The primary outcome was the percentage of VLBW infants who had received early antibiotics (ampicillin, gentamicin, or cefotaxime on the day of birth or day 1 or 2 after birth), antibiotics for longer than 3 days (despite negative blood culture), or no antibiotics. Results: During the study period, a significant relative reduction was seen in the proportion of VLBW infants administered early antibiotics (46%; p < 0.01) and in infants provided antibiotics for longer than 3 days (90%; p < 0.01). Additionally, the percentage of VLBW with "no antibiotics" during their NICU stay increased fivefold (6 to 30%; p < 0.001). Conclusions: In our NICU, the implementation of a QI initiative that is based on affordable methods to track process indicators and evaluate the results led into a significant reduction in antibiotic exposure in VLBW infants. This approach is easy to implement in other NICUs as well.

Mother's Bed Incline and Desaturation Episodes in Healthy Term Newborns during Early Skin-to-Skin Contact: A Multicenter Randomized Controlled Trial.

INTRODUCTION: Early skin-to-skin contact (ESSC) is associated with rare, sudden, unexpected postnatal collapse episodes. Placing the newborn in ESSC closer to an upright position may reduce the risk of airway obstruction and improve respiratory mechanics. This study assessed whether a greater inclination of the mother's bed during ESSC would reduce the proportion of healthy term newborns (HTNs) who experienced episodes of pulse oximeter saturation (SpO2) <91%. METHODS: We conducted a multicenter randomized controlled trial comparing the effect of the mother's bed incline, 45° versus 15°, on desaturation in HTNs during ESSC. Before delivery on 1,271 dyads, randomization was conducted, and stringent criteria to select healthy mothers and term newborns were monitored until after birth. Preductal SpO2 was continuously monitored between 10 min and 2 h after birth. The primary outcome was the occurrence of at least one episode of SpO2 <91%. RESULTS: 254 (20%) mother-infant dyads were eligible for analysis (45°, n = 126; 15°, n = 128). Overall, 57% (95% confidence interval [CI]: 51%-63%) of newborns showed episodes of SpO2 <91%. The proportion of infants with SpO2 <91% episodes was 52% in 45° and 62% in 15° (relative risk: 0.80; 95% CI: 0.6-1.07). CONCLUSIONS: We did not show that a high mother bed inclination during ESSC led to significantly fewer HTNs who experienced episodes of SpO2 <91%. Desaturation episodes from 10 min to 2 h after birth occurred in more than half of HTNs.

Sex Differences in Chronic Thromboembolic Pulmonary Hypertension. Treatment Options over Time in a National Referral Center.

(1) Background: Clinical presentation, disease distribution, or treatment received may provide insights into the reasons contributing to sex differences in chronic thromboembolic pulmonary hypertension (CTEPH). (2) Methods: We evaluated 453 patients (56% women) between 2007-2019. Data was collected from REHAP (Registro Español de Hipertensión Arterial Pulmonar) registry. Two time periods were selected to evaluate the influence of new treatments over time. (3) Results: Women were older. Baseline functional class was worse, and distance walked shorter in women compared with men. Women had higher pulmonary vascular resistances. Despite this, pulmonary endarterectomy (PEA) was carried out in more men, and women received more frequently pulmonary vasodilators exclusively. The 2014-2019 interval was associated with a better survival only among women. Interestingly, women had a more distal disease during this second period of time. (4) Conclusions: Even though women were older, and received invasive treatments less frequently, mortality was similar in both sexes. The introduction of balloon pulmonary angioplasty and the improvement of pulmonary endarterectomy, especially during the last years, could be associated with a survival benefit among women.

What is the impact of mother's bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial.

BACKGROUND: Early mother-child skin-to-skin contact (SSC) in the first 2 h postpartum is highly beneficial for both mother and child. However, cases have been reported of newborns who have experienced apparently life-threatening events (ALTEs) or sudden death during this procedure. The causes of these events are unknown. Newborn's prone position could influence the onset of these events but there is very little evidence to support any recommendation. We hypothesize that newborns' breathing obstruction episodes increase as mothers lie more horizontally. The main objective of this study is to compare the occurrence of desaturation and bradycardia episodes as a function of mother's bed incline. The study is designed as a randomized, controlled, assessor blind, multicenter, superiority trial with two parallel groups and 1:1 allocation ratio. METHODS: The study participants will be full-term healthy mother-newborn dyads from ten hospitals in Spain. Participants will be randomly assigned to one of two study arms defined by mother's bed inclination (45° or 15°). The planned sample size is 5866. Centralized permuted blocks randomization and assessor blinding will be implemented. The newborns will be monitored remotely with pulse oximetry, from 10 min to 2 h after delivery. We established SO2 and heart rate (HR) limit alarms, as well as an action protocol in the event of alarm activation. The primary outcome is the number of healthy newborns who undergo episodes of SO2 ≤ 90%. Secondary outcomes are the mean SO2 level, the number of newborns who experience episodes of SO2 ≤ 85%, the time to SSC discontinuation due to abnormal SO2 or HR, and episodes of HR < 111 beats per minute (bpm) or > 180 bpm. Subgroups and pooled analysis will be performed to identify if breast-feeding and mother and child positions favor the occurrence of desaturation or bradycardia episodes. DISCUSSION: A simple intervention such as modifying mother's bed angle of inclination while in SSC with her child during the first 2 h postpartum could favor newborn's hemodynamic and respiratory stabilization and thus contribute to reducing the onset of ALTEs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02585492 . Registered on 22nd October 2015. PROTOCOL VERSION: 2 (30th June 2015).

Spanish survey on follow-up programmes for children born very preterm.

AIM: To describe variations in practice between follow-up programmes for very preterm children born at less than 32 weeks' gestation or with very low birth weight of less than 1,500 g. METHODS: A survey on follow-up practices was electronically distributed to level II and III units among hospitals of the Spanish National Health Service in 2016. The survey included 70 questions covering issues such as follow-up organisation and resources, routine assessments, relationships with other services and families, information management and training. RESULTS: The response rate was 91.5% (141/154). Among respondents, 70.9% (100/141) reported that they do provide follow-up and 42% do so up to six years of age. Routine neurological and ophthalmological follow-up is not performed in 60% and 37% of hospitals, respectively, and a second hearing assessment is not given in 62%. Just 38% of units have psychologist. In 41% of hospitals, training in follow-up skills is not included in Paediatric Residency training programme. CONCLUSION: Although Spain has a nationwide health system that provides universal health coverage, we found that follow-up care for children born very preterm/very low birth weight is not equitable. Nearly half of paediatric residents receive no training in follow-up for this high-risk population.

Model that predicted death or disabilities in premature infants was valid at seven years of age.

AIM: Validated a model that used bronchopulmonary dysplasia (BPD), brain injuries measured using ultrasound and retinopathy of prematurity (ROP) to predict late death or disability in premature infants at seven years of age. METHODS: A retrospective study was performed at the 12 de Octubre Hospital neonatal unit in Madrid. A logistic model was applied to estimate the independent prognostic contribution of each morbidity, and the effect that the combination of morbidities had on the seven-year outcomes. The analysis was performed on the total cohort from 1991 to 2008 and on two subcohorts from 1991 to 1998 and 1999 to 2008. RESULTS: A total of 1001 children were included with a mean birth weight of 922 ± 208 g. Severe ROP was strongly associated with poor neurodevelopment, with an odds ratio (OR) 3.17 and 95% confidence interval (CI) of 1.56-6.50, and so was BPD (OR 1.52, 95% CI: 1.03-2.2). The combination of two neonatal morbidities increased the risk of a poor outcome (OR 4.44, 95% CI: 1.51-7.86). The model behaved differently in the two subcohorts. CONCLUSION: The prognostic model predicted a poor outcome at seven years of age when the subjects had at least two of the three morbidities.

Auditing of Monitoring and Respiratory Support Equipment in a Level III-C Neonatal Intensive Care Unit.

BACKGROUND: Random safety audits (RSAs) are a safety tool but have not been widely used in hospitals. OBJECTIVES: To determine the frequency of proper use of equipment safety mechanisms in relation to monitoring and mechanical ventilation by performing RSAs. The study also determined whether factors related to the patient, time period, or characteristics of the area of admission influenced how the device safety systems were used. METHODS: A prospective observational study was conducted in a level III-C Neonatal Intensive Care Unit (NICU) during 2012. 87 days were randomly selected. Appropriate overall use was defined when all evaluated variables were correctly programmed in the audited device. RESULTS: A total of 383 monitor and ventilator audits were performed. The Kappa coefficient of interobserver agreement was 0.93. The rate of appropriate overall use of the monitors and respiratory support equipment was 33.68%. Significant differences were found with improved usage during weekends, OR 1.85 (1.12-3.06, p = 0.01), and during the late shift (3 pm to 10 pm), OR 1.59 (1.03-2.4, p = 0.03). CONCLUSIONS: Equipment safety systems of monitors and ventilators are not properly used. To improve patient safety, we should identify which alarms are really needed and where the difficulties lie for the correct alarm programming.

How the Body Position Can Influence High-resolution Manometry Results in the Study of Esophageal Dysphagia and Gastroesophageal Reflux Disease.

BACKGROUND/AIMS: The body position can influence esophageal motility data obtained with high-resolution manometry (HRM). To examine whether the body position influences HRM diagnoses in patients with esophageal dysphagia and gastroesophageal reflux disease (GERD). METHODS: HRM (Manoscan) was performed in 99 patients in the sitting and supine positions; 49 had dysphagia and 50 had GERD as-sessed by 24-hour pH monitoring. HRM plots were analyzed according to the Chicago classification. RESULTS: HRM results varied in the final diagnoses of the esophageal body (EB) in patients with dysphagia (P = 0.024), the result being more distal spasm and weak peristalsis while sitting. In patients with GERD, the HRM diagnoses of the lower esophageal sphinc-ter (LES), the esophagogastric junction (EGJ) morphology, and EB varied depending on the position; (P = 0.063, P = 0.017, P = 0.041 respectively). Hypotensive LES, EGJ type III (hiatal hernia), and weak peristalsis were more frequently identified in the sitting position. The reliability (kappa) of the position influencing HRM diagnoses was similar in dysphagia and GERD ("LES diagnosis": dysphagia 0.32 [0.14-0.49] and GERD 0.31 [0.10-0.52], P = 0.960; "EB diagnosis": dysphagia 0.49 [0.30-0.69] and GERD 0.39 [0.20-0.59], P = 0.480). The reliability in "EGJ morphology" studies was higher in dysphagia 0.81 (0.68-0.94) than in GERD 0.55 (0.37-0.73), P = 0.020. CONCLUSIONS: HRM results varied according to the position in patients with dysphagia and GERD. Weak peristalsis was more frequently diagnosed while sitting in dysphagia and GERD. Hypotensive LES and EGJ type III (hiatal hernia) were also more frequently diagnosed in the sitting position in patients with GERD.

Type of homogenization and fat loss during continuous infusion of human milk.

BACKGROUND: Substantial fat loss may occur during continuous feeding of human milk (HM). A decrease of fat loss has been described following homogenization. Well-established methods of homogenization of HM for routine use in the neonatal intensive care unit (NICU) would be desirable. OBJECTIVE: We compared the loss of fat based on the use of 3 different methods for homogenizing thawed HM during continuous feeding. METHODS: Sixteen frozen donor HM samples were thawed, homogenized with ultrasound and separated into 3 aliquots ("baseline agitation," "hourly agitation," and "ultrasound"), and then frozen for 48 hours. Aliquots were thawed again and a baseline agitation was applied. Subsequently, aliquots baseline agitation and hourly agitation were drawn into a syringe, while ultrasound was applied to aliquot ultrasound before it was drawn into a syringe. The syringes were loaded into a pump (2 mL/h; 4 hours). At hourly intervals the hourly agitation infusion was stopped, the syringe was disconnected and gently shaken. During infusion, samples from the 3 groups were collected hourly for analysis of fat and caloric content. RESULTS: The 3 groups of homogenization showed similar fat content at the beginning of the infusion. For fat, mean (SD) hourly changes of -0.03 (0.01), -0.09 (0.01), and -0.09 (0.01) g/dL were observed for the hourly agitation, baseline agitation, and ultrasound groups, respectively. The decrease was smaller for the hourly agitation group (P < .001). CONCLUSION: When thawed HM is continuously infused, a smaller fat loss is observed when syringes are agitated hourly versus when ultrasound or a baseline homogenization is used.

How useful is esophageal high resolution manometry in diagnosing gastroesophageal junction disruption: causes affecting this disruption and its relationship with manometric alterations and gastroesophageal reflux.

BACKGROUND: High-resolution manometry (HRM) is a breakthrough in the morphological study of the gastroesophageal junction (GEJ) and its degrees of disruption. OBJECTIVES: a) Assessment of risk factors involved in the disruption of the GEJ in patients with gastroesophageal reflux (GER) symptoms; b) the relationship between the type of GEJ and GER demonstrated by 24 hours pH-monitoring; and c) identification of the alterations in the manometric parameters related to the morphology of the GEJ. METHODS: One hundred and fifteen patients with symptoms of GER studied with HRM and classified by the type of GEJ (type I: Normal; type II: Sliding; type III: Hiatal hernia). Twenty four hour pH-monitoring without proton pump inhibitors was performed in all of them. Epidemiological aspects, manometric parameters (Chicago 2012 classification) and the pH-monitoring results were evaluated. RESULTS: Age (OR 1.033 [1.006-1.060]; p = 0.16), BMI (OR 1.097 [1.022-1.176]; p = 0. 01) and abdominal perimeter (OR 1.034 [1.005-1.063]; p = 0.0215) were independent risk factors for the GEJ type III (area under the curve 0.70). Disruption of the GEJ was associated with a lower resting pressure (p = 0.006), greater length (p < 0.001) and greater esophageal shortening (p < 0.001). Abnormal acidic reflux was found in the total period (p = 0.015), standing (p = 0.022) and supine (p = 0.001) in patients with GEJ type II and III with respect to type I. CONCLUSIONS: Increased age, overweight and central obesity pose a higher risk of GEJ type III (hiatal hernia). The greater disruption of the GEJ is associated with lower resting pressure, esophageal shortening, and higher acid exposure in the pH-monitoring.

Validation of the Spanish version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).

BACKGROUND: To evaluate the psychometric properties of the Spanish version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and its effectiveness as a screening tool for problematic alcohol, tobacco and other psychoactive substance use in groups of low, moderate, and high risk users. METHODS: A test battery including the ASSIST and several standardized screening, assessment, and diagnostic instruments was administered to 485 patients recruited in different primary health-care facilities and specialized addiction treatment units from Health Area 11 in Madrid. RESULTS: ASSIST cut-off scores show a good sensitivity and specificity for discrimination between substance use and abuse and between abuse and dependence. Concurrent validity was demonstrated by significant correlations between ASSIST scores and scores from the Mini-International Neuropsychiatric Interview (MINI-Plus), the Alcohol Use Disorders Identification Test (AUDIT), the Revised Fagerstrom Tolerance Questionnaire (RTQ) and the Severity of Dependence Scale (SDS). CONCLUSIONS: Psychometric properties of the Spanish version of the ASSIST indicate that is a valid screening test for identifying substance use disorders in various health-care settings.