Étude de l’impact de déterminants psycho-socio-environnementaux sur la santé physique et mentale des femmes enceintes vivant dans un contexte linguistique et culturel minoritaire

La barrière linguistique réduirait le recours aux services préventifs, l’accès aux services basés sur la communication et augmenterait le recours aux services d’urgence. Les femmes sont particulièrement à risque à cause de leurs besoins accrus de services de santé et de soutien psychosociaux durant la grossesse, l’accouchement et la période du post-partum. Cette étude vise à recueillir de l’information sur les expériences de maternité des femmes francophones (Canadiennes et immigrantes) du Nouveau-Brunswick et de l’Alberta. Les résultats de cette étude seront utilisés pour améliorer les soins de santé et l’accès à l’information pour les femmes enceintes en situation linguistique et culturel minoritaire.Linguistic barriers may reduce the use of preventative services and access to communication-based services, and increase the use of emergency care. Women are particularly at risk owing to their increased need for health services and psychosocial support during pregnancy, birth and the post-partum period. We gathered information on the maternity experiences of Francophone women (Canadians and immigrants) in New Brunswick and Alberta. The results of the study will be used to improve health care and access to information for pregnant women in linguistic and cultural minority situations

Parental characteristics and perspectives pertaining to neonatal visits to the emergency department: a multicentre survey

BACKGROUND: Parents take neonates to the emergency department for many reasons, often nonurgent, pressuring an already burdened system. We aimed to characterize these visits and families to identify potential strategies to decrease neonatal emergency department visits. METHODS: We developed and implemented a survey that explored characteristics of neonates and parents/guardians evaluated in the emergency department, perspectives of parents and use of health care services. Parents presenting with a neonate to the emergency department in 5 large academic hospitals in Ontario were surveyed between December 2013 and June 2015. We used descriptive statistics to report survey data and explored correlations between factors. RESULTS: A total of 1533 surveys were completed. The most common reasons for presenting were jaundice (441 [28.8%]) and feeding issues (251 [16.4%]). The majority of respondents (73.9% [1104/1494]) had received advice before going to the emergency department. In most cases (86.4% [954/1104]), this was from a health care provider, who frequently advised going to the emergency department. Although most parents (86.8% [1280/1475]) reported high confidence in caring for a sick or injured child, 42.3% (643/1519) were unsure of the severity, and most (90.4% [578/639]) of these parents felt that the infant required assessment immediately or the same day. Of parents who felt the condition was not serious, 83.2% (198/238) thought that same-day evaluation was required. Nearly half of respondents (44.4% [621/1400]) said they would have gone to their health care provider with a same-day appointment, and 28.1% (344/1225) would have gone to their care provider with a next-day appointment. INTERPRETATION: Parents\u27 reported confidence in caring for sick or injured infants does not match the perceived urgency of neonatal conditions, which likely contributes to emergency department overuse. Any system to decrease nonurgent emergency department use by neonates would need to be immediately responsive, providing same-day help

Influence of Common Non-Synonymous Toll-like Receptor 4 Polymorphisms on Bronchopulmonary Dysplasia and Prematurity in Human Infants

Bronchopulmonary dysplasia (BPD) is a common chronic lung disease and major risk factor for severe respiratory syncytial virus (RSV) infection among preterm infants. The Toll-like receptor 4 (TLR4) is involved in oxidative injury responses in the lungs. Two non-synonymous single nucleotide polymorphisms in the TLR4 gene have been associated with RSV infection in children. However, it is unclear to what extent this association is confounded by BPD or prematurity. In this study, we analyzed two population-based cohorts of preterm infants at risk for BPD as well as ethnicity-matched infants born at term, to test whether the TLR4 polymorphisms Asp299Gly (rs4986790) and Thr399Ile (rs4986791) are independently associated with BPD or premature birth. In a Canadian cohort (n = 269) composed of a majority of Caucasian preterm infants (BPD incidence of 38%), the TLR4-299 heterozygous genotype was significantly under-represented in infants without BPD (1.6% of infants versus 12% in infants with severe BPD) after adjusting for twins, ethnicity, gestational age, birth weight and gender (p = 0.014). This association was not replicated in a Finnish cohort (n = 434) of premature singletons or first-born siblings of Caucasian descent, although the incidence of BPD was substantially lower in this latter population (15%). We did not detect a significant association (>2-fold) between TLR4 genotypes and prematurity (p>0.05). We conclude that these TLR4 genotypes may have, at best, a modest influence on BPD severity in some populations of high-risk preterm infants. Further studies are warranted to clarify how clinical heterogeneity may impact genetic susceptibility to BPD

Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale

Introduction: To ensure the quality of clinical trial safety data, universal data standards are required. In 2019 the International Neonatal Consortium (INC) published a neonatal adverse event severity scale (NAESS) to standardize the reporting of adverse event (AE) severity. In this study the reliability of AE severity grading with INC NAESS was prospectively assessed in a real-world setting. Methods: Severity of AEs was assessed by two independent observers at each of four centers across the world. In each center two series of 30 neonatal adverse events were assessed by both observers: in a first phase with a generic (Common Terminology Criteria for Adverse Events, CTCAE) severity scale not specific to neonates, and in a second phase with INC NAESS (after a structured training). Intraclass correlation coefficients (ICC) were calculated to express inter-rater agreement in both phases, and bootstrap sampling was used to compare them. Results: 120 AEs were included in each of both phases. The ICC with the use of INC NAESS in phase 2 was 0.69. This represents a significant but modest improvement in comparison to the initial ICC of 0.66 in phase 1 (confidence interval of ratio of ICC in phase 2 to phase 1 = 1.005–1.146; excludes 1). The ICC was higher for those AEs for which a diagnosis specific AE severity table was available in INC NAESS (ICC 0.80). Discussion: Good inter-rater reliability of the INC NAESS was demonstrated in four neonatal intensive care units (NICUs) across the globe. The ICC is comparable to what is reported for scales with similar purposes in different populations. There is a modest, but significant, improvement in inter-rater agreement in comparison to the naïve phase without INC NAESS. The better performance when reviewers use AE-specific NAESS tables highlights the need to expand the number of AEs that are covered by specific criteria in the current version of INC NAESS.</p

Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)

Abstract Background Apnoea of prematurity (AOP) is one of the most common diagnoses among preterm infants. AOP often leads to hypoxemia and bradycardia which are associated with an increased risk of death or disability. In addition to caffeine therapy and non-invasive respiratory support, doxapram might be used to reduce hypoxemic episodes and the need for invasive mechanical ventilation in preterm infants, thereby possibly improving their long-term outcome. However, high-quality trials on doxapram are lacking. The DOXA-trial therefore aims to investigate the safety and efficacy of doxapram compared to placebo in reducing the composite outcome of death or severe disability at 18 to 24 months corrected age. Methods The DOXA-trial is a double blinded, multicentre, randomized, placebo-controlled trial conducted in the Netherlands, Belgium and Canada. A total of 396 preterm infants with a gestational age below 29 weeks, suffering from AOP unresponsive to non-invasive respiratory support and caffeine will be randomized to receive doxapram therapy or placebo. The primary outcome is death or severe disability, defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness, at 18–24 months corrected age. Secondary outcomes are short-term neonatal morbidity, including duration of mechanical ventilation, bronchopulmonary dysplasia and necrotising enterocolitis, hospital mortality, adverse effects, pharmacokinetics and cost-effectiveness. Analysis will be on an intention-to-treat principle. Discussion Doxapram has the potential to improve neonatal outcomes by improving respiration, but the safety concerns need to be weighed against the potential risks of invasive mechanical ventilation. It is unknown if the use of doxapram improves the long-term outcome. This forms the clinical equipoise of the current trial. This international, multicentre trial will provide the needed high-quality evidence on the efficacy and safety of doxapram in the treatment of AOP in preterm infants. Trial registration ClinicalTrials.gov NCT04430790 and EUDRACT 2019-003666-41. Prospectively registered on respectively June and January 2020

Cell-Based Therapy for Bronchopulmonary Dysplasia in Preterm Infants: Workshop report

Bronchopulmonary dysplasia (BPD) is the most common complication of extreme prematurity. Currently, there is no specific treatment available. Preclinical studies support cell-therapy as a promising therapy for BPD in preterm infants. A successful translation to a safe and effective clinical intervention depends on multiple factors including the perspective of neonatal health care providers. A 2 hour workshop with 40 Canadian neonatologists was held to enhance the design of a phase II trial of stem cells for babies at risk for BPD, with a focus on the population to target and the outcomes to measure in such a trial. The consensus was that infants recruited in an early trial of stem cells should be the ones with the highest risk of developing severe BPD. This risk should be established based on known antenatal, perinatal and postnatal risk factors. The primary outcome in a phase II trial will be focussed on a non-clinical outcome (e.g. a dose finding- or a safety-study). With other aspects of a translational study discussed, this workshop contributed to accelerate the design of a first Canadian clinical cell-therapy study for BPD in preterm infants.The accepted manuscript in pdf format is listed with the files at the bottom of this page. The presentation of the authors' names and (or) special characters in the title of the manuscript may differ slightly between what is listed on this page and what is listed in the pdf file of the accepted manuscript; that in the pdf file of the accepted manuscript is what was submitted by the author

Effect of Prophylaxis for Early Adrenal Insufficiency Using Low-Dose Hydrocortisone in Very Preterm Infants: An Individual Patient Data Meta-Analysis

International audienceObjectiveTo assess the effect of prophylaxis for early adrenal insufficiency using low-dose hydrocortisone on survival without bronchopulmonary dysplasia (BPD) in very preterm infants using an individual patient data meta-analysis.Study designAll existing randomized controlled trials testing the efficacy of the prophylaxis of early adrenal insufficiency using low-dose hydrocortisone on survival without BPD were considered for inclusion when data were available. The primary outcome was the binary variable survival without BPD at 36 weeks of postmenstrual age.ResultsAmong 5 eligible studies, 4 randomized controlled trials had individual patient data available (96% of participants identified; n = 982). Early low-dose hydrocortisone treatment for 10-15 days was associated with a significant increase in survival without BPD (OR, 1.45; 95% CI, 1.11-1.90; P = .007; I2 = 0%), as well as with decreases in medical treatment for patent ductus arteriosus (OR, 0.72; 95% CI, 0.56-0.93; P = .01; I2 = 0%) and death before discharge (OR, 0.70; 95% CI, 0.51-0.97; P = .03; I2 = 0%). The therapy was associated with an increased risk of spontaneous gastrointestinal perforation (OR, 2.50; 95% CI, 1.33-4.69; P = .004; I2 = 31.9%) when hydrocortisone was given in association with indomethacin exposure. The incidence of late-onset sepsis was increased in infants exposed to hydrocortisone (OR, 1.34; 95% CI, 1.02-1.75; P = .04; I2 = 0%), but no adverse effects were reported for either death or 2-year neurodevelopmental outcomes as assessed in an aggregate meta-analysis.ConclusionsThis individual patient data meta-analysis showed that early low-dose hydrocortisone therapy is beneficial for survival without BPD in very preterm infants

Perception du contexte linguistique et culturel minoritaire sur le vécu de la grossesse

International audienceFrom a public health perspective, the follow-up of women during pregnancy and the perinatal period requires quality communication and health services that take into account the context in which these women live. However, challenges related to access to health services in French in a minority situation have been documented in recent research. The objective of this pilot study is to better understand the perceptions, the lived experiences and the needs of pregnant Francophone women living in Canada within a linguistic minority context. Given the exploratory nature of the inquiry, a mixed method descriptive study was conducted in Alberta and New Brunswick, whose populations are 2% and 33% Francophone, respectively. Two semi-structured interviews and a series of validated questionnaires were administered to 21 pregnant women during the third trimester of pregnancy and at six weeks postnatal. Based on the questionnaires, a descriptive analysis documented participants' characteristics, and qualitative interviews were transcribed, coded and analyzed through an inductive process by four independent readers to uncover key themes related to the participants' experiences. Most of the women were bilingual and language in which health services were received did not appear to be a major issue for them, except during times of stress and at critical periods of the pregnancy. In contrast, almost one third of the women reported being unsatisfied with services they had received and attributed this dissatisfaction to gaps in French language services. Women prefer to receive health services in their mother tongue, however services are delivered in English most of the time. Participants report that during times of stress and emergency, communication in French is essential to a quality follow-up of patients. Linguistic and cultural congruence seems to be a key factor for quality care during pregnancy. A comparative study would assist in better ascertaining the relative impact of language on Francophone women's lived experiences during pregnancy.OBJECTIF : Dans une perspective de santé publique, le suivi de grossesse et la période périnatale exigent une communication de qualité et des servicesde santé qui tiennent compte du contexte dans lequel ces femmes évoluent. Or, des défis d’accès aux services de santé en français en situationminoritaire au Canada ont été documentés. Cette étude pilote a pour objectif de mieux cerner les perceptions et le vécu de femmes enceintesfrancophones vivant au Canada dans un contexte linguistique minoritaire.MÉTHODES : Étant donné la nature exploratoire du questionnement, une étude descriptive alliant des méthodes quantitative et qualitative a été mis en oeuvre en Alberta et au Nouveau-Brunswick, dont les populations sont de 2 % et 33 % francophones, respectivement. Deux entrevues semi-structurées et une série de questionnaires ont été administrées auprès de 21 femmes enceintes au début du troisième trimestre de grossesse et à six semaines après la naissance. Une analyse descriptive des questionnaires a permis de dresser le profil et les caractéristiques des participantes, et les entrevues qualitatives,transcrites, codées et analysées de façon inductive par quatre lecteurs indépendants, ont fait ressortir plusieurs thèmes clés en rapport avec leursexpériences.RÉSULTATS : La plupart des participantes se sont dites bilingues et la langue ne semble pas avoir été un enjeu majeur dans l’évaluation des services desanté reçus sauf en situation de stress et lors de certaines périodes critiques de la grossesse et de l’accouchement. Par contre, près d’un tiers desparticipants se disent insatisfaites des services de santé reçus et l’insuffisance de suivi en français est mentionnée comme un des facteurs contribuant àcette insatisfaction.CONCLUSION : Les services de santé sont préférés dans la langue maternelle des femmes mais reçus dans la langue de la majorité la plupart du temps.En situation de stress ou de complication de grossesse, les témoignages des participantes semblent indiquer que la communication en français est unfacteur essentiel d’un suivi de grossesse de qualité. Une étude comparative permettrait de mieux distinguer l’impact spécifique de la langue dansl’expérience vécue des femmes enceintes