Vécu moral des parents lors des prises de décision de traitement : rapport d'un service de réanimation pédiatrique français

Mémoire numérisé par la Direction des bibliothèques de l'Université de Montréal

The role of parenting stress in anxiety and sleep outcomes in toddlers with congenital heart disease

ObjectivesThis retrospective cohort study investigates how parenting stress, measured at 4 months of age by use of a classic three-dimensional parent-reported scale (Parenting Stress Index, 4th Ed. or PSI-4), can predict anxiety symptoms and quality of sleep at 24 months in toddlers with congenital heart disease (CHD).Study DesignSixty-six toddlers with CHD followed at our cardiac neurodevelopmental follow-up clinic were included in this study. As part of their systematic developmental assessment program, parents completed questionnaires on their stress level (PSI-4) when their child was 4 months old, and on their child's anxiety symptoms and quality of sleep at 24 months. Eight multiple linear regression models were built on the two measures collected at 24 months using the PSI-4 scores collected at 4 months. For each measure, four models were built from the PSI-4 total score and its three subscales (Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child), controlling for sex and socioeconomic status.ResultsThe PSI-4 Difficult Child subscale, which focuses on parenting anxiety related to the child's behavioral problems and poor psychosocial adjustment, accounted for 17% of the child's anxiety symptoms at 24 months. The two other PSI-4 subscales (Parental Distress and Parent-Child Dysfunctional Interaction) and the PSI-4 total score did not contribute significantly to the models. None of the four regression models on perceived quality of sleep were significant. It is important to note that 33% of parents responded defensively to the PSI-4.ConclusionsParenting stress related to the child's behavioral problems and poor psychosocial adjustment, measured when the child is 4 months old, is associated with the child's ulterior anxiety symptoms. As very few standardized tools are available to assess the behavioral and psychoaffective development of infants, this study highlights the importance of early psychosocial screening in parents of infants with CHD. The high rate of significant Defensive Responding Indices reminds us to not take parent reports at face value, as their actual stress levels might be higher

A Parent–child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol

Introduction Preschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent–child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations.Methods and analysis This is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent–child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 6-month follow-up; (3) adherence to the intervention; (4) acceptability of the randomisation process by families; (5) heterogeneity in the delivery of the intervention between instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size.Ethics and dissemination Ethical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings.Trial registration number NCT05997680

Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

International audienceBackground Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants. Methods Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures. Results Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modified intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute difference and 95% CI − 0.1% [− 8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (− 3.2% [− 9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a significant interaction between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated participants were on average 11 years older, with more comorbidities.Conclusion This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu ( 2022-500385-99-00 )