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Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed.
To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au.
This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5–0.9 mg/kg or midazolam 0.025–0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4.
The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1–69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2–8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h.
Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.
The antipsychotic aripiprazole is often used in the treatment of first-episode psychosis. Measuring aripiprazole blood levels provides an objective measure of treatment adherence, but this currently involves taking a venous blood sample and sending to a laboratory for analysis.
To detail the development, validation and utility of a new point of care (POC) test for finger-stick capillary blood concentrations of aripiprazole.
Analytical performance (sensitivity, precision, recovery and linearity) of the assay were established using spiked whole blood and control samples of varying aripiprazole concentration. Assay validation was performed over a 14-month period starting in July 2021. Eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Capillary blood samples were tested by the MyCare™ Insite POC analyser, which provided measurement of aripiprazole concentration in 6 min, and the venous blood sample was tested by the standard laboratory method.
A total of 101 patients agreed to measurements by the two methods. Venous blood aripiprazole concentrations as assessed by the laboratory method ranged from 17 to 909 ng/mL, and from 1 to 791 ng/mL using POC testing. The correlation coefficient between the two methods (r) was 0.96 and there was minimal bias (slope 0.91, intercept 4 ng/ml).
The MyCare Insite POC analyser is sufficiently accurate and reliable for clinical use. The availability of this technology will improve the assessment of adherence to aripiprazole and the optimising of aripiprazole dosing.
People with post-traumatic stress disorder (PTSD) exhibit negative cognitions, predictive of PTSD severity. The Post-Traumatic Cognitions Inventory (PTCI) is a widely used instrument measuring trauma-related cognitions and beliefs with three subscales: negative thoughts of self (SELF), negative cognitions about the world (WORLD), and self-blame (BLAME).
The current study attempted to validate the use of the PTCI in people with serious mental illness (SMI), who have greater exposure to trauma and elevated rates of PTSD, using confirmatory factor analysis (CFA) and examining convergent and divergent correlations with relevant constructs.
Participants were 432 individuals with SMI and co-occurring PTSD diagnosis based on the Clinician Administered PTSD Scale, who completed PTCI and other clinical ratings.
CFAs provided adequate support for Foa’s three-factor model (SELF, WORLD, BLAME), and adequate support for Sexton’s four-factor model that also included a COPE subscale. Both models achieved measurement invariance at configural, metric and scalar levels for three diagnostic groups: schizophrenia, bipolar and major depression, as well as for ethnicity (White vs Black), and gender (male vs female). Validity of both models was supported by significant correlations between PTCI subscales, and self-reported and clinician assessed PTSD symptoms and associated symptoms.
Findings provide support for the psychometric properties of the PTCI and the conceptualization of Sexton’s four-factor and Foa’s three-factor models of PTCI among individuals diagnosed with SMI (Foa et al., 1999).
Maternal fish consumption exposes the fetus to beneficial nutrients and potentially adverse neurotoxicants. The current study investigated associations between maternal fish consumption and child neurodevelopmental outcomes. Maternal fish consumption was assessed in the Seychelles Child Development Study Nutrition Cohort 1 (n 229) using 4-day food diaries. Neurodevelopment was evaluated at 9 and 30 months, and 5 and 9 years with test batteries assessing twenty-six endpoints and covering multiple neurodevelopmental domains. Analyses used multiple linear regression with adjustment for covariates known to influence child neurodevelopment. This cohort consumed an average of 8 fish meals/week and the total fish intake during pregnancy was 106·8 (sd 61·9) g/d. Among the twenty-six endpoints evaluated in the primary analysis there was one beneficial association. Children whose mothers consumed larger quantities of fish performed marginally better on the Kaufman Brief Intelligence Test (a test of nonverbal intelligence) at age 5 years (β 0·003, 95 % CI (0, 0·005)). A secondary analysis dividing fish consumption into tertiles found no significant associations when comparing the highest and lowest consumption groups. In this cohort, where fish consumption is substantially higher than current global recommendations, maternal fish consumption during pregnancy was not beneficially or adversely associated with children’s neurodevelopmental outcomes.
Adverse childhood experiences (ACE) can affect educational attainments, but little is known about their impact on educational achievements in people at clinical high risk of psychosis (CHR).
In total, 344 CHR individuals and 67 healthy controls (HC) were recruited as part of the European Community’s Seventh Framework Programme-funded multicenter study the European Network of National Schizophrenia Networks Studying Gene–Environment Interactions (EU-GEI). The brief version of the Child Trauma Questionnaire was used to measure ACE, while educational attainments were assessed using a semi-structured interview.
At baseline, compared with HC, the CHR group spent less time in education and had higher rates of ACE, lower rates of employment, and lower estimated intelligence quotient (IQ). Across both groups, the total number of ACE was associated with fewer days in education and lower level of education. Emotional abuse was associated with fewer days in education in HC. Emotional neglect was associated with a lower level of education in CHR, while sexual abuse was associated with a lower level of education in HC. In the CHR group, the total number of ACE, physical abuse, and neglect was significantly associated with unemployment, while emotional neglect was associated with employment.
ACE are strongly associated with developmental outcomes such as educational achievement. Early intervention for psychosis programs should aim at integrating specific interventions to support young CHR people in their educational and vocational recovery. More generally, public health and social interventions focused on the prevention of ACE (or reduce their impact if ACE occur) are recommended.
While shared clinical decision-making (SDM) is the preferred approach to decision-making in mental health care, its implementation in everyday clinical practice is still insufficient. The European Psychiatric Association undertook a study aiming to gather data on the clinical decision-making style preferences of psychiatrists working in Europe.
We conducted a cross-sectional online survey involving a sample of 751 psychiatrists and psychiatry specialist trainees from 38 European countries in 2021, using the Clinical Decision-Making Style – Staff questionnaire and a set of questions regarding clinicians’ expertise, training, and practice.
SDM was the preferred decision-making style across all European regions ([central and eastern Europe, CEE], northern and western Europe [NWE], and southern Europe [SE]), with an average of 73% of clinical decisions being rated as SDM. However, we found significant differences in non-SDM decision-making styles: participants working in NWE countries more often prefer shared and active decision-making styles rather than passive styles when compared to other European regions, especially to the CEE. Additionally, psychiatry specialist trainees (compared to psychiatrists), those working mainly with outpatients (compared to those working mainly with inpatients) and those working in community mental health services/public services (compared to mixed and private settings) have a significantly lower preference for passive decision-making style.
The preferences for SDM styles among European psychiatrists are generally similar. However, the identified differences in the preferences for non-SDM styles across the regions call for more dialogue and educational efforts to harmonize practice across Europe.
This critical and empirical article explores contemporary reproduction, experience, and responses to stigma in welfare delivery in Ireland. Combining qualitative data about lone parents (n22) gathered through two different research projects in 2017 and 2018 allows us to interrogate stigma in a multi-dimensional way and as an overarching experience as an ongoing project of neo liberalism. We analyse our findings using Baumberg’s (2016) typology of stigma which differentiates claim making stigma from personal and societal stigma, applying the framework to empirical data concerning lone parents’ recent experiences of Irish labour activation and homeless support services. We find that while behavioural conditionality necessarily frames this experience and constrains claimants, it is not totalising. We conclude by using Tyler’s concept of stigmacraft to situate the context of stigma as part of the political economy of welfare.
In view of the increasing complexity of both cardiovascular implantable electronic devices (CIEDs) and patients in the current era, practice guidelines, by necessity, have become increasingly specific. This document is an expert consensus statement that has been developed to update and further delineate indications and management of CIEDs in pediatric patients, defined as ≤21 years of age, and is intended to focus primarily on the indications for CIEDs in the setting of specific disease categories. The document also highlights variations between previously published adult and pediatric CIED recommendations and provides rationale for underlying important differences. The document addresses some of the deterrents to CIED access in low- and middle-income countries and strategies to circumvent them. The document sections were divided up and drafted by the writing committee members according to their expertise. The recommendations represent the consensus opinion of the entire writing committee, graded by class of recommendation and level of evidence. Several questions addressed in this document either do not lend themselves to clinical trials or are rare disease entities, and in these instances recommendations are based on consensus expert opinion. Furthermore, specific recommendations, even when supported by substantial data, do not replace the need for clinical judgment and patient-specific decision-making. The recommendations were opened for public comment to Pediatric and Congenital Electrophysiology Society (PACES) members and underwent external review by the scientific and clinical document committee of the Heart Rhythm Society (HRS), the science advisory and coordinating committee of the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association for European Paediatric and Congenital Cardiology (AEPC). The document received endorsement by all the collaborators and the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). This document is expected to provide support for clinicians and patients to allow for appropriate CIED use, appropriate CIED management, and appropriate CIED follow-up in pediatric patients.
Psychosis is associated with a reasoning bias, which manifests as a tendency to ‘jump to conclusions’. We examined this bias in people at clinical high-risk for psychosis (CHR) and investigated its relationship with their clinical outcomes.
In total, 303 CHR subjects and 57 healthy controls (HC) were included. Both groups were assessed at baseline, and after 1 and 2 years. A ‘beads’ task was used to assess reasoning bias. Symptoms and level of functioning were assessed using the Comprehensive Assessment of At-Risk Mental States scale (CAARMS) and the Global Assessment of Functioning (GAF), respectively. During follow up, 58 (16.1%) of the CHR group developed psychosis (CHR-T), and 245 did not (CHR-NT). Logistic regressions, multilevel mixed models, and Cox regression were used to analyse the relationship between reasoning bias and transition to psychosis and level of functioning, at each time point.
There was no association between reasoning bias at baseline and the subsequent onset of psychosis. However, when assessed after the transition to psychosis, CHR-T participants showed a greater tendency to jump to conclusions than CHR-NT and HC participants (55, 17, 17%; χ2 = 8.13, p = 0.012). There was a significant association between jumping to conclusions (JTC) at baseline and a reduced level of functioning at 2-year follow-up in the CHR group after adjusting for transition, gender, ethnicity, age, and IQ.
In CHR participants, JTC at baseline was associated with adverse functioning at the follow-up. Interventions designed to improve JTC could be beneficial in the CHR population.
Background: Certain nursing home (NH) resident care tasks have a higher risk for multidrug-resistant organisms (MDRO) transfer to healthcare personnel (HCP), which can result in transmission to residents if HCPs fail to perform recommended infection prevention practices. However, data on HCP-resident interactions are limited and do not account for intrafacility practice variation. Understanding differences in interactions, by HCP role and unit, is important for informing MDRO prevention strategies in NHs. Methods: In 2019, we conducted serial intercept interviews; each HCP was interviewed 6–7 times for the duration of a unit’s dayshift at 20 NHs in 7 states. The next day, staff on a second unit within the facility were interviewed during the dayshift. HCP on 38 units were interviewed to identify healthcare personnel (HCP)–resident care patterns. All unit staff were eligible for interviews, including certified nursing assistants (CNAs), nurses, physical or occupational therapists, physicians, midlevel practitioners, and respiratory therapists. HCP were asked to list which residents they had cared for (within resident rooms or common areas) since the prior interview. Respondents selected from 14 care tasks. We classified units into 1 of 4 types: long-term, mixed, short stay or rehabilitation, or ventilator or skilled nursing. Interactions were classified based on the risk of HCP contamination after task performance. We compared proportions of interactions associated with each HCP role and performed clustered linear regression to determine the effect of unit type and HCP role on the number of unique task types performed per interaction. Results: Intercept-interviews described 7,050 interactions and 13,843 care tasks. Except in ventilator or skilled nursing units, CNAs have the greatest proportion of care interactions (interfacility range, 50%–60%) (Fig. 1). In ventilator and skilled nursing units, interactions are evenly shared between CNAs and nurses (43% and 47%, respectively). On average, CNAs in ventilator and skilled nursing units perform the most unique task types (2.5 task types per interaction, Fig. 2) compared to other unit types (P < .05). Compared to CNAs, most other HCP types had significantly fewer task types (0.6–1.4 task types per interaction, P < .001). Across all facilities, 45.6% of interactions included tasks that were higher-risk for HCP contamination (eg, transferring, wound and device care, Fig. 3). Conclusions: Focusing infection prevention education efforts on CNAs may be most efficient for preventing MDRO transmission within NH because CNAs have the most HCP–resident interactions and complete more tasks per visit. Studies of HCP-resident interactions are critical to improving understanding of transmission mechanisms as well as target MDRO prevention interventions.
Funding: Centers for Disease Control and Prevention (grant no. U01CK000555-01-00)
Disclosures: Scott Fridkin, consulting fee, vaccine industry (spouse)
Background: Shared Healthcare Intervention to Eliminate Life-threatening Dissemination of MDROs in Orange County, California (SHIELD OC) was a CDC-funded regional decolonization intervention from April 2017 through July 2019 involving 38 hospitals, nursing homes (NHs), and long-term acute-care hospitals (LTACHs) to reduce MDROs. Decolonization in NH and LTACHs consisted of universal antiseptic bathing with chlorhexidine (CHG) for routine bathing and showering plus nasal iodophor decolonization (Monday through Friday, twice daily every other week). Hospitals used universal CHG in ICUs and provided daily CHG and nasal iodophor to patients in contact precautions. We sought to evaluate whether decolonization reduced hospitalization and associated healthcare costs due to infections among residents of NHs participating in SHIELD compared to nonparticipating NHs. Methods: Medicaid insurer data covering NH residents in Orange County were used to calculate hospitalization rates due to a primary diagnosis of infection (counts per member quarter), hospital bed days/member-quarter, and expenditures/member quarter from the fourth quarter of 2015 to the second quarter of 2019. We used a time-series design and a segmented regression analysis to evaluate changes attributable to the SHIELD OC intervention among participating and nonparticipating NHs. Results: Across the SHIELD OC intervention period, intervention NHs experienced a 44% decrease in hospitalization rates, a 43% decrease in hospital bed days, and a 53% decrease in Medicaid expenditures when comparing the last quarter of the intervention to the baseline period (Fig. 1). These data translated to a significant downward slope, with a reduction of 4% per quarter in hospital admissions due to infection (P < .001), a reduction of 7% per quarter in hospitalization days due to infection (P < .001), and a reduction of 9% per quarter in Medicaid expenditures (P = .019) per NH resident. Conclusions: The universal CHG bathing and nasal decolonization intervention adopted by NHs in the SHIELD OC collaborative resulted in large, meaningful reductions in hospitalization events, hospitalization days, and healthcare expenditures among Medicaid-insured NH residents. The findings led CalOptima, the Medicaid provider in Orange County, California, to launch an NH incentive program that provides dedicated training and covers the cost of CHG and nasal iodophor for OC NHs that enroll.
Disclosures: Gabrielle M. Gussin, University of California, Irvine, Stryker (Sage Products): Conducting studies in which contributed antiseptic product is provided to participating hospitals and nursing homes. Clorox: Conducting studies in which contributed antiseptic product is provided to participating hospitals and nursing homes. Medline: Conducting studies in which contributed antiseptic product is provided to participating hospitals and nursing homes. Xttrium: Conducting studies in which contributed antiseptic product is provided to participating hospitals and nursing homes.
Background: As many as 40% of infants aged ≤12 months and 10%–28% of children aged 13–24 months are colonized by Clostridioides difficile. The IDSA and the SHEA recommend that testing should never be routinely recommended for infants ≤12 months of age and should not be routinely performed for children 1–2 years of age unless other causes are excluded. We report implementation of C. difficile diagnostic stewardship at 2 children’s hospitals. Methods: We implemented age-based restrictions for C. difficile testing at hospital A (∼200-bed, free-standing, children’s hospital) and hospital B (∼100-bed children’s hospital within a larger hospital). Both sites are part of the same multicampus institution, and both used nucleic acid amplification testing to detect C. difficile throughout the study. In May 2018, we implemented an electronic order set for C. difficile that provided alerts to avoid testing young infants and patients with recent use of laxatives, stool softeners, or enemas, but providers could order C. difficile testing at their discretion. In October 2018, we implemented a more restrictive diagnostic stewardship algorithm for C. difficile. No testing was allowed for infants aged ≤12 months. Approval pediatric infectious diseases staff was required to test children aged 13–24 months. Pathology resident approval was required to test children aged ≥24 months who had received laxatives, stool softeners, or enemas within ≤24 hours. Clinical microbiology laboratory supervisors reinforced rejection of nondiarrheal stool specimens for testing. Providers at both campuses were informed about the new testing guidelines by e-mail. We compared the number of tests sent and positive cases of healthcare facility-onset C. difficile (HO-CDI) by age strata before and after the implementation of the restrictive testing algorithm. Results: After the intervention, the number of tests in infants significantly declined; 2 infants aged ≤12 months and 4 infants aged 13–24 months were tested for C. difficile (Table). After the intervention, the number of tests per month declined at hospital A, as did the number of HO-CDI cases at both hospitals. Rejections of nondiarrheal stools significantly increased after the intervention (P < .001). Conclusions:C. difficile diagnostic stewardship for children was successfully implemented using a rule-based alert system in the electronic health record. This intervention was associated with a reduced number of tests sent and cases of HO-CDI. This strategy was cost-saving and prevented misdiagnosis, unnecessary antibiotic therapy, and overestimation of HO-CDI rates.
Evidence from observational studies indicates that seaweed consumption may reduce the risk of non-communicable diseases such as cardiovascular disease, type two diabetes, and obesity. Accumulating evidence from in vitro and animal studies suggest seaweed have antihyperlipidemic, anti-inflammatory and antioxidant properties which may in part be attributed to the high content of soluble dietary fibre in seaweeds. The viscosity of seaweed fibres is suggested to mediate antihyperlipdiemic effects via the alteration of lipid/bile acid absorption kinetics to decrease low-density lipoprotein cholesterol (LDL). Thus, there is a need to evaluate the efficacy of seaweed derived dietary fibre in the management of dyslipidemia. Therefore, the aim of this study was to determine the effect of a fibre rich extract from Palmaria palmata on the lipid profile as well as markers of inflammation and oxidative stress in healthy adults. A total of 60 healthy participants (30 male and 30 female) aged 20 to 58 years, were assigned to consume the Palmaria palmata fibre extract (5g/day), Synergy-1 and the placebo (maltodextrin) for a duration of 4 weeks with a minimum 4 week washout between each treatment in a double blind, randomised crossover study conducted over 5 months. Fasting concentrations of cholesterol, triglycerides and high-density lipoprotein cholesterol (HDL) were analysed and low-density lipoprotein cholesterol (LDL) and LDL: HDL ratio was calculated. C-reactive protein (CRP) and Ferric Reducing Ability of Plasma (FRAP) were analysed as markers of inflammation and oxidative stress, respectively. Supplementation for 4 weeks with Palmaria palmata resulted in favourable changes to lipid profiles with a reduced LDL:HDL ratio; however intention-to-treat univariate ANCOVA identified no significant difference between the treatment groups over time on any of the lipid profile markers. A non-significant increase in CRP and triglyceride concentration along with lower FRAP was also observed with Palmaria palmata supplementation. Evidence from this study suggests that Palmaria palmata may have effects on lipid metabolism and appears to mobilise triglycerides. More research is needed in individuals with dyslipidaemia to fully elucidate these effects.
Applying the concept of burnout to medical students before residency is relatively recent. Its estimated prevalence varies significantly between studies. Our objective was to estimate the prevalence of burnout in medical students worldwide.
We systematically searched Medline for English-language articles published between January 1, 2010 and December 31, 2017. We selected all the original studies about the prevalence of burnout in medical students before residency, using validated questionnaires for burnout. Statistical analyses were conducted using the OpenMetaAnalyst software.
Prevalence of current burnout was extracted from 24 studies encompassing 17,431 medical students. Among them, 8060 suffered from burnout and we estimated the prevalence to be 44.2% [33.4%–55.0%]. The information about the prevalence of each subset of burnout dimensions was given in nine studies including 7588 students. Current prevalence was estimated to be 40.8% for ‘emotional exhaustion’ [32.8%–48.9%], 35.1% [27.2%–43.0%] for ‘depersonalization’ and 27.4% [20.5%–34.3%] for ‘personal accomplishment’. There is no significant gender difference in burnout. The prevalence of burnout is slightly different across countries with a higher prevalence in Oceania and the Middle East than in other continents.
The results of this meta-analysis suggest that one student out of two is suffering from burnout, even before residency. Again, our findings highlight the high level of distress in the medical population. These results should encourage the development of preventive strategies.
As many as 70% of intensive care unit (ICU) survivors suffer from long-term physical, cognitive, and psychological impairments known as post-intensive care syndrome (PICS). We describe how the first ICU survivor clinic in the United States, the Critical Care Recovery Center (CCRC), was designed to address PICS using the principles of Agile Implementation (AI).
The CCRC was designed using an eight-step process known as the AI Science Playbook. Patients who required mechanical ventilation or were delirious ≥48 hours during their ICU stay were enrolled in the CCRC. One hundred twenty subjects who completed baseline HABC-M CG assessments and had demographics collected were included in the analysis to identify baseline characteristics that correlated with higher HABC-M CG scores. A subset of patients and caregivers also participated in focus group interviews to describe their perceptions of PICS.
Quantitative analyses showed that the cognitive impairment was a major concern of caregivers. Focus group data also confirmed that caregivers of ICU survivors (n = 8) were more likely to perceive cognitive and mental health symptoms than ICU survivors (n = 10). Caregivers also described a need for ongoing psychoeducation about PICS, particularly cognitive and mental health symptoms, and for ongoing support from other caregivers with similar experiences.
Our study demonstrated how the AI Science Playbook was used to build the first ICU survivor clinic in the United States. Caregivers of ICU survivors continue to struggle with PICS, particularly cognitive impairment, months to years after discharge. Future studies will need to examine whether the CCRC model of care can be adapted to other complex patient populations seen by health-care professionals.
Prematurity impacts myocardial development and may determine long-term outcomes. The objective of this study was to test the hypothesis that preterm neonates develop right ventricle dysfunction and adaptive remodelling by 32 weeks post-menstrual age that persists through 1 year corrected age.
Materials and Methods:
A subset of 80 preterm infants (born <29 weeks) was selected retrospectively from a prospectively enrolled cohort and measures of right ventricle systolic function and morphology by two-dimensional echocardiography were assessed at 32 weeks post-menstrual age and at 1 year of corrected age. Comparisons were made to 50 term infants at 1 month and 1 year of age. Sub-analyses were performed in preterm-born infants with bronchopulmonary dysplasia and/or pulmonary hypertension.
In both term and preterm infants, right ventricle function and morphology increased over the first year (p < 0.01). The magnitudes of right ventricle function measures were lower in preterm-born infants at each time period (p < 0.01 for all) and right ventricle morphology indices were wider in all preterm infants by 1 year corrected age, irrespective of lung disease. Measures of a) right ventricle function were further decreased and b) morphology increased through 1 year in preterm infants with bronchopulmonary dysplasia and/or pulmonary hypertension (p < 0.01).
Preterm infants exhibit abnormal right ventricle performance with remodelling at 32 weeks post-menstrual age that persists through 1 year corrected age, suggesting a less developed intrinsic myocardial function response following preterm birth. The development of bronchopulmonary dysplasia and pulmonary hypertension leave a further negative impact on right ventricle mechanics over the first year of age.