O objetivo desse estudo é conhecer a implantação da Unidade Neonatal e as práticas de atendimento adotadas durante essa implantação pelos profissionais de saúde no Hospital de Clínicas de Porto Alegre (HCPA), Rio Grande do Sul. Considerara-se como práticas de atendimento as ações dirigidas ao recém-nascido e à sua família, realizadas pelos profissionais de saúde durante o processo de hospitalização do neonato. Trata-se de um estudo qualitativo fundamentado no referencial teórico da Nova História, usando a história oral como estratégia de coleta de dados, através das entrevistas semi-estruturadas. Outras fontes de dados foram materiais como rotinas, escalas, estatutos, cartas, fita de VHS, planta baixa e slides de projeção visual. O recorte temporal utilizado abrange o período desde 1972, quando teve inicio a elaboração do projeto de implantação da unidade, até o final do primeiro mandato das chefias de enfermagem e médica, em 1984. Os informantes seguiram os critérios de inclusão, tendo totalizado 15 profissionais da área da saúde sendo três médicos, dez Enfermeiras, uma técnica de enfermagem e um auxiliar de enfermagem. A análise dos dados foi do tipo temática realizada com o auxílio do software Nvivo, versão 7.0, obtendo-se dois temas: Implantação da Unidade Neonatal e Práticas de Atendimento. Na implantação neonatal ficou evidenciada, pelos profissionais da saúde, a criação de um campo de atuação na área neonatal, com ênfase na tecnologia que permitisse aumentar a sobrevida do neonato. As práticas de atendimento foram pautadas pela preocupação em unificar as condutas embasadas cientificamente e em valorizar os avanços tecnológicos. Essas práticas também consistiram da implantação das rotinas que permitiram a permanência dos pais junto ao recém-nascido durante todo o período de hospitalização. Entretanto, a valorização tecnológica e do cientificismo acabaram se sobrepondo à valorização do recém-nascido como um ser pertencente a uma família / This study has the objective of knowing the implantation of a neonatal unit and the care practices adopted in this implantation by the health professionals in the Hospital de Clínicas de Porto Alegre, in the state of Rio Grande do Sul, Brazil. Care practices have been considered the actions addressed to the newborn and its family performed by the health professionals during the process of hospitalization of the neonate. It is a qualitative study founded in the theoretical referential of the New History, by utilizing the oral history as strategy of data collection through semi-structured interview. Other data sources used were routines, scales, laws, letters, VHS tapes, ground plan and slides of visual projection. The time frame comprised the period from 1972, when the elaboration of the project for the implantation of the unit started, to the end of the first term of office of the nursing and medical management in 1984. The informing subjects followed the inclusion criteria totaling 15 professionals from the health area comprising 3 physicians, 10 nurses, 1 nursing technician and 1 nursing assistant. The analysis of the data followed the thematic model carried out with the support of the NVivo software (version 7.0). Thus, two themes were obtained: Implantation of the Neonatal Unit and Care Practices. In the neonatal implantation, the health professionals evidenced that the creation of a performance field in the neonatal field with emphasis in the technology that allowed increased outlive of the neonate. The care practices, in its turn, featured the concern about unifying the scientifically-based conducts and valuing the technological breakthroughs, besides the implantation of the routines that allowed the stay of their parents together with the newborn during the entire hospitalization period. However, the technological and scientific valuation finally imposed itself over the valuation of the newborn as a being belonging to a family. / El estudio tiene como objetivo conocer la implantación de la unidad neonatal y las prácticas de cuidado adoptadas en este período, por los profesionales de salud, en el Hospital de Clínicas de Porto Alegre, Rio Grande do Sul. Se consideraron como prácticas de cuidado las acciones dirigidas al recién-nacido y su familia realizadas por los profesionales de salud durante el proceso de hospitalización del neonato. Se trata de un estudio cualitativo fundamentado en el referencial teórico de la Nueva Historia, utilizando la historia oral como estrategia de recolección de datos, a través de entrevistas semi-estructuradas y otras fuentes de datos materiales como rutinas, escalas, estatutos, cartas, cinta de VHS, planta baja y diapositivas de proyección visual. El recorte temporal utilizado abarca el período desde 1972, cuando tuvo inicio la elaboración del proyecto de implantación de la unidad hasta el final del primer mandato de las jefaturas de enfermería y médica en 1984. Los informantes siguieron los criterios de inclusión totalizando 15 profesionales del área de la salud siendo 3 médicos, 10 enfermeras, 1 técnica de enfermería y 1 auxiliar de enfermería. El análisis de los datos fue del tipo temático realizado con el auxilio del programa NVivo (versión 7.0). Así, fueron obtenidos dos temas: Implantación de la Unidad Neonatal y Prácticas de Cuidado. En la implantación neonatal quedó evidenciado, por los profesionales de la salud, la creación de un campo de actuación en el área neonatal con énfasis en la tecnología que permitiera aumentar la sobrevida del neonato. Las prácticas de cuidado, a su vez, se caracterizaron por la preocupación en unificar las conductas embasadas científicamente y en valorar los avances tecnológicos, además de la implantación de las rutinas que permitieron la permanencia de sus padres junto al recién-nacido durante todo el período de hospitalización. No obstante, la valoración tecnológica y del cientificismo terminó por se sobreponer a la valoración del recién-nacido como un ser perteneciente a una familia.

The preterm delivery (<37 weeks gestation) rates are generally 5-9% in Europe, 12-13% in the US, and each year about 13 millions preterm infants are born worldwide (MacDorman and Mathews, 2009; Slattery and Morrison, 2002). The early exposure to the extra-uterine environment increases the risks of perinatal brain injury, involving more often the white matter. The white matter injury is characterized by a potential subsequent occurrence of cognitive problems, of developmental delay and of major motor deficits (e.g. cerebral palsy). <p>The most widely used imaging technique for studying neonatal brain is cranial ultrasound that can be performed at bedside and detects major brain abnormalities (hemorrhage, infarctions, cysts, dilatation of the lateral ventricles). However, it has a poor sensitivity for non-cystic or diffuse white matter abnormalities (WMA), the most common form of white matter injury in preterm infants. In comparison to ultrasound, MR (magnetic resonance) imaging has been reported to be superior in detecting WMA and is considered as an essential modality for imaging the neonatal brain. The standard sequences (e.g. T1-, T2-weighted imaging) are routinely performed for assessing not only brain anatomy, but also for evaluating brain lesions. Nevertheless, ¡§conventional MR imaging¡¨ has been criticized because it is limited in qualitative assessment and it does not provide information on the extent of specific white matter pathways injuries. <p>Currently, diffusion tensor imaging (DTI) enables more detailed exploration of white matter microstructure. Furthermore, DTI is now the best in vivo technique capable of delineating white matter pathways and quantifying microstructural changes not visible on conventional MR imaging. Diffusion tensor tractography allows the reconstruction of the principal white matter fibers. Moreover, it also provides diffusion indices like fractional anisotropy (FA), mean diffusivity (MD), longitudinal diffusivity (£f//), transverse diffusivity (£f¢r) that help assess the changes in fiber tracts, even before myelination becomes histologically evident. <p>Structural MR imaging studies performed in neonates are scarce. A number of essential questions are still under debate, concerning the normal white matter structure, as well as premature brain injury. First, left language lateralization and right handedness are complex phenomena incompletely understood and the question rises whether structural lateralization already exist in healthy preterm neonates at term-equivalent age. Second, it is of interest to know whether gender-related structural differences exist in healthy preterm neonates. Finally, in the assessment of preterm brain injury, the relationship between WMA on conventional imaging and altered diffusion indices in fiber tracts is still unclear. Therefore, the aims of the thesis were to investigate the brain structure in a population of preterm neonates at term-equivalent age by DTI and probabilistic tractography.<p>The first part of this thesis (Study I and Study II) was devoted to the study of white matter structural characteristics in healthy preterm neonates. Previous studies have shown that structural asymmetries in language and motor related fibers are present in adults and in infants (Dubois et al. 2009; Westerhausen et al. 2007). Our hypothesis was that these structural asymmetries are already present in preterm neonates at term-equivalent age. In Study I, DTI and probabilistic tractography were performed and we found volume and microstructural asymmetries in the language related parieto-temporal superior longitudinal fasciculi (SLF), in the motor related corticospinal tract (CST) and in the motor part of the superior thalamic radiation (STR) as well. In Study II, we found that compared to boys, girls have larger relative tract volumes and an advanced maturation in language and motor related fiber tracts. <p>The second part of this thesis (Study III) investigated whether WMA on conventional MR imaging are related to abnormalities within the fiber tract microstructures. WMA were classified as normal, mild, moderate and severe according to Woodward¡¦s classification (Woodward et al. 2006). Woodward and colleagues studied a large population (167 infants) of preterm infants at term equivalent age with MRI. They demonstrated that WMA were important predictors of neurological outcomes by comparing their results with the neurological outcomes of those infants at corrected age of two. We found that compared to neonates with no abnormalities, infants with mild abnormalities have significantly higher ƒÜ¢r in the right CST, the left anterior thalamic radiation (ATR), the left sensory STR and bilateral motor STR. Those findings might be related to injuries of premyelinating oligodendrocytes resulting in subsequent failure of both development and ensheathment of axons. Considering that those fiber tracts connect important cortical zones, microstructural changes in those fiber tracts might be responsible for the later neurodevelopment deficits in motor and cognitive functions. <p>We concluded that structural asymmetries and gender differences in motor and language related fibers are present in healthy preterm neonates at term-equivalent age well before the development of speech and hand preference. Structural asymmetries and gender differences have to be considered in neonatal white matter assessment. Finally, altered DTI indices are associated with WMA on conventional MR imaging in preterm neonates. Our results suggest that disrupted premyelination is the major correlate with WMA rather than axonal pathology. Non-invasive DTI and tractography constitute an additional tool for the assessment of white matter injuries, as it could provide more adequate diagnostic information on brain microstructure in preterm neonates at term-equivalent age. / Doctorat en Sciences médicales / info:eu-repo/semantics/nonPublished

Les nouveau-nés ne sont pas des patients comme les autres. Contrairement aux patients plus âgés, il existe pour les nouveau-nés des recommandations qui guident leur prise en charge ou leur non-prise en charge dès la naissance en fonction de critères spécifiques, notamment l’âge gestationnel. Or l’âge gestationnel est imprécis, et demeure un mauvais prédicteur de la survie ou du pronostic des nouveau-nés. De tels critères ne sont pas utilisés pour les patients plus âgés. En plus d’être réanimés différemment, les nouveau-nés décèdent aussi autrement. Contrairement aux patients plus âgés qui décèdent majoritairement en recevant des soins actifs à visée curative, de nombreux nouveau-nés décèdent suite à une décision de réorientation de soins, et souvent ceux-ci meurent malgré une relative stabilité physiologique, en raison d’inquiétudes se rapportant à leur qualité de vie future. Lorsqu’interrogés, malgré le fait qu’une majorité d’intervenants en santé croient que la réanimation d’un nouveau-né fragile ou à risque à la naissance est dans son meilleur intérêt, une majorité presqu’équivalente d’intervenants seraient prêts à redéfinir ce meilleur intérêt en fonction de la famille et à malgré tout à lui offrir des soins de confort. Ceci n’est pas le cas avec les patients plus âgés. Cette dévalorisation est expliquée par le fait que les nouveau-nés sont perçus comme moralement différents des patients plus âgés. Les raisons de ce statut moral particulier sont multiples, mais incluent notamment le contexte historique et socioculturel, l’absence de relations sociales préexistantes, un attachement perçu comme étant moindre, et l’influence de biais, de valeurs et d’expériences personnelles et professionnelles défavorables aux nouveau-nés. Nous croyons que cette différence de statut moral doit être identifiée et reconnue, et doit alimenter certaines réflexions professionnelles et sociales, notamment par rapport à sa désirabilité et aux conséquences qui en découlent. / Neonates are different. Contrary to older patients, professional guidelines specifically addressing the resuscitation or the non-resuscitation of neonates have been established and are being used by healthcare institutions worldwide. These guidelines are mostly built around gestational age criteria. Unfortunately, gestational age is imprecise and is not a good predictor of survival or long-term prognosis. This may not be the typical perspective when dealing with older patients. Not only are neonates resuscitated differently, their modes of death are also not the same. Unlike older patients who mostly die while receiving acute care, many neonates die following a decision to withdraw or withhold care, and the majority of these die in a condition of relative physiologic stability because of concerns for their future quality of life. When investigated or surveyed, even though a majority of health care providers believe resuscitating a fragile neonate is in the baby’s best interest, a similar majority is also willing to redefine this best interest according to family wishes and to accept comfort care. This is not the case with older patients. This devaluation is explained by the fact that neonates are perceived as being morally different. The reasons explaining this difference in moral status are many but include the historical and socio-cultural context, the absence of long standing pre-existing social relationships, an attachment to neonates that is perceived as being inferior, and the influence of professional and personal biases, values, and experiences that are unfavorable to neonates. We believe this difference in conferred moral status needs to be recognized and acknowledged, and should further professional and social reflections about its desirability and consequences.

Thèse numérisée par la Division de la gestion de documents et des archives de l'Université de Montréal.

Les nouveau-nés prématurés sont à risque de développer des séquelles neurodéveloppementales pouvant se manifester de la petite enfance jusqu’à l’âge adulte. La relation mère-enfant précoce figure parmi les facteurs pouvant améliorer leur neurodéveloppement. La principale composante de cette relation est la sensibilité maternelle, soit la capacité de détecter, d’interpréter et de répondre rapidement aux besoins du nouveau-né. Cependant, en raison de l’immaturité des nouveau-nés prématurés ainsi que du stress et de l’anxiété vécus par les mères pendant l’hospitalisation, celles-ci sont à risque de développer une sensibilité maternelle sous-optimale. De par leurs compétences, leurs valeurs et leurs activités réservées, les infirmières à l’unité de soins intensifs néonatals (USIN) jouent un rôle de premier plan pour favoriser la sensibilité maternelle dès l’hospitalisation des nouveau-nés prématurés. Les données scientifiques actuelles ne sont suffisantes ni en quantité ni en qualité afin d’orienter les interventions que pourraient concrètement réaliser les infirmières auprès de la dyade mère-nouveau-né prématuré afin de favoriser de façon très précoce, soit dès l’hospitalisation, la sensibilité maternelle. Le but de la thèse comportait deux volets : 1- développer une intervention infirmière très précoce selon une approche combinant la théorie et les données empiriques pour favoriser la sensibilité maternelle et le neurodéveloppement des nouveau-nés prématurés à l’USIN; et 2- mettre à l’essai et évaluer la faisabilité, l’acceptabilité et estimer les effets préliminaires de l’intervention infirmière sur la sensibilité maternelle et le neurodéveloppement des nouveau-nés prématurés à l’USIN. Une intervention infirmière novatrice multifactorielle nommée GP_Posit a été développée. GP_Posit est une intervention individuelle hebdomadaire durant laquelle l’infirmière crée une relation de participation guidée avec la mère, dans un contexte de participation aux soins et au positionnement du nouveau-né prématuré. Basée sur la Théorie de l’Attachement, la Théorie de la Participation Guidée et la Théorie Synactive du Développement, GP_Posit est principalement conçue afin de favoriser la sensibilité maternelle et le neurodéveloppement du nouveau-né prématuré. Ensuite, une étude pilote randomisée à deux groupes a été menée dans une USIN de niveau III d’un centre hospitalier universitaire mère-enfant. Au total, 20 dyades composées de mères et de leur nouveau-né prématuré ont été recrutées et randomisées au groupe expérimental (GP_Posit; n=10) ou au groupe contrôle (soins standards; n=10). Les résultats montrent que GP_Posit est faisable et acceptable pour les mères de nouveau-nés prématurés ainsi que pour l’équipe de recherche. Toutefois, au niveau de la faisabilité et l’acceptabilité du devis relatif à l’essai clinique randomisé, des difficultés ont été rencontrées au niveau du recrutement et la collecte de données au post-test. Les effets préliminaires estimés montrent une tendance vers un effet large indiquant une augmentation de la sensibilité maternelle chez les mères du groupe expérimental. Quant à l’effet préliminaire sur le neurodéveloppement, les nouveau-nés prématurés du groupe contrôle étaient légèrement favorisés. Une seconde étude pilote permettrait de mettre à l’essai des procédures modifiées de recrutement et collecte de données au post-test. Éventuellement, un essai contrôlé randomisé multicentrique à grande échelle permettra d’apprécier davantage les effets de GP_Posit sur la sensibilité maternelle et le neurodéveloppement des nouveau-nés prématurés. / Preterm infants are at risk of neurodevelopmental impairments which can manifest from infancy through adulthood. The early mother-infant relationship is one of the factors that can improve their neurodevelopment. The main component of this relationship is maternal sensitivity, that is the mother’s ability detect, interpret and respond in an appropriate and timely manner to her infant’s needs. However, due to the immaturity of preterm infants as well as the stress and anxiety experienced by mothers during hospitalization, they are at risk of developing suboptimal maternal sensitivity. Neonatal nurses play a key role and have the necessary skills to promote maternal sensitivity in the neonatal intensive care unit (NICU). However, the current evidence is neither sufficient nor of sufficiently good quality to guide the interventions that could be implemented by neonatal nurses to promote maternal sensitivity in the NICU. The aim of the thesis was twofold: 1- develop an innovative very early nursing intervention using an approach combining theory and empirical data to promote maternal sensitivity and neurodevelopment of preterm infants in the NICU; and 2- to implement and assess the feasibility, acceptability and estimate of the preliminary effects of this nursing intervention on maternal sensitivity and neurodevelopment of preterm infants in the NICU. A very early multifaceted nursing intervention named GP_Posit was developed. GP_Posit is a weekly individual intervention where nurses create a guided participation relationship with mothers, in a context of participation in care and positioning of the preterm infant. Based on Attachment Theory, Guided Participation Theory and Synactive Theory of Development, GP_Posit is primarily designed to promote maternal sensitivity and neurodevelopment of the preterm infant. A two-group randomized pilot study was conducted in a level III NICU of a mother-infant teaching hospital. A total of 20 dyads composed of mothers and preterm infants were recruited and randomized to the experimental group (GP_Posit; n = 10) or control group (standard care; n = 10). Results show that GP_Posit is feasible and acceptable for mothers of preterm infants as well as for the research team. Regarding the feasibility and acceptability of the randomized controlled trial study design, challenges were encountered in the recruitment and post-test data collection procedures. The preliminary effects showed a trend towards a large effect in increasing maternal sensitivity in experimental group mothers. As for the preliminary effect on neurodevelopment, preterm infants in the control group had an advantage. A second pilot study would be the opportunity to test modified recruitment and post-test data collection procedures. Eventually, a large-scale, multicenter randomized controlled trial would allow a better understanding of the effectiveness of GP_Posit on maternal sensitivity and preterm infant neurodevelopment.

Indiana University-Purdue University Indianapolis (IUPUI) / Objectives: To determine (1) whether prescribed and delivered energy and protein intakes during the first two weeks of life met Ziegler’s estimated requirements for Very Low Birth Weight (VLBW) infants, (2) if actual energy during the first week of life correlated with time to regain birth weight and reach full enteral nutrition (EN) defined as 100 kcal/kg/day, (3) if growth velocity from time to reach full EN to 36 weeks’ postmenstrual age (PMA) met Ziegler’s estimated fetal growth velocity (16 g/kg/day), and (4) growth outcomes at 36 weeks’ PMA. Study design: Observational study of feeding, early nutrition and early growth of 40 VLBW infants ≤ 30 weeks GA at birth in three newborn intensive care units NICUs. Results: During the first week of life, the percentages of prescribed and delivered energy (69% [65 kcal/kg/day]) and protein (89% [3.1 g/kg/day]) were significantly less than theoretical estimated requirements. Delivered intakes were 15% less than prescribed because of numerous interruptions in delivery and medical complications. During the second week, the delivered intakes of energy (90% [86 kcal/kg/day]) and protein (102% [3.5 g/kg/day]) improved although the differences between prescribed and delivered were consistently 15%. Energy but not protein intake during the first week was significantly related to time to reach full EN. Neither energy nor protein intake significantly correlated with days to return to birth weight. The average growth velocity from the age that full EN was attained to 36 weeks’ PMA (15 g/kg/day) was significantly less than the theoretical estimated fetal growth velocity (16 g/kg/day) (p<0.03). A difference of 1 g/kg/day represents a total deficit of 42 - 54 grams over the course of a month. At 36 weeks’ PMA, 53% of the VLBW infants had extrauterine growth restriction, or EUGR (<10th percentile) on the Fenton growth grid and 34% had EUGR on the Lubchenco growth grid. Conclusions: The delivered nutrient intakes were consistently less than 15% of the prescribed intakes. Growth velocity between the age when full EN was achieved and 36 weeks’ PMA was 6.7% lower than Ziegler’s estimate. One-third to one-half of the infants have EUGR at 36 weeks’ PMA.

Cotutelle de thèse / Depuis quelques décennies, il est admis que les nouveau-nés prématurés (moins de 37 semaines de gestation complétées) ressentent la douleur, et semblent y être particulièrement vulnérables. La douleur répétée et non traitée engendre d’importantes répercussions pour les prématurés, telles qu’une hypersensibilité à la douleur et un impact sur le développement cérébral, soit des conséquences jusqu’à sept ans de vie : diminution du volume cérébral, altérations de la microstructure de la matière blanche et modifications de l’activité cérébrale. La douleur chez les prématurés est un phénomène complexe qui est influencé par de nombreux facteurs liés aux caractéristiques spécifiques du prématuré, aux professionnels de la santé et aux parents. Malgré de nombreuses études de diverses disciplines depuis plusieurs décennies, le soulagement de la douleur des prématurés demeure une préoccupation actuelle étant donné le manque d’interventions efficaces, d’où la nécessité de poursuivre les recherches. Afin de guider adéquatement la recherche, l’utilisation d’une théorie permet de définir et de circonscrire les éléments qui seront évalués ainsi que les moyens utilisés pour l’évaluation des variables ciblées, l’interprétation des résultats et leurs retombées. Actuellement, aucune théorie portant sur la douleur procédurale des prématurés n’a été recensée dans les écrits scientifiques. Le but général de cette thèse était de développer, d’évaluer et d’adapter une théorie portant sur la gestion de la douleur procédurale des prématurés afin d’offrir une perspective théorique regroupant différents éléments influençant l’évaluation et le soulagement de la douleur auprès de cette clientèle. Le développement de la théorie Pain Assessment and INterventions in Neonatology (PAIN-Neo) a été réalisée à partir d’une analyse critique des perspectives théoriques existantes en douleur pédiatrique ainsi que par le biais d’une revue exhaustive des écrits visant à recenser les facteurs impliqués dans la gestion de la douleur des prématurés au niveau empirique. De plus, les connaissances et l’expertise de l’étudiante-chercheuse en néonatologie ont permis d’ajouter l’influence des différentes catégories de soins de développement qui visent à promouvoir le développement neurologique du prématuré. Une perspective philosophique réaliste critique sous-tend le développement de la théorie PAIN-Neo, amenant à identifier les différentes configurations Contexte-Mécanismes-Effets pour chaque acteur impliqué dans l’évaluation et le soulagement de la douleur, soit le prématuré, les professionnels de la santé et les parents. L’évaluation de certains liens postulés dans cette théorie a été effectuée par la réalisation d’une revue systématique avec une méta-analyse de données recueillies chez les prématurés (n=1028) et d’une étude transversale quantitative auprès d’infirmières oeuvrant en néonatologie (n=202). Ces études ont permis d’évaluer certains liens établis dans la théorie et de l’adapter à la lumière du volet empirique. La théorie PAIN-Neo qui a été développée dans le cadre de cette thèse propose une vision innovante de la gestion de la douleur procédurale chez le prématuré, pour les chercheurs et les cliniciens en néonatologie, en intégrant le prématuré, les professionnels de la santé et les parents, tout en considérant les différents facteurs individuels et contextuels influençant la douleur pour ces trois acteurs. La théorie PAIN-Neo offre une base théorique afin de guider des recherches impliquant un ou plusieurs de ces acteurs et pour soutenir le développement de guides de pratique clinique reflétant adéquatement la complexité de la gestion de la douleur chez les prématurés. / For several decades, it has been recognized that the preterm infants (less than 37 completed weeks gestation) feel pain and appears to be particularly vulnerable to it. Repeated and untreated pain has important consequences for preterm infants, such as hypersensitivity to pain and impact on brain development, with consequences up to seven years of life: decrease in brain volume, alterations in white matter microstructure and changes in brain activity. Pain in preterm infants is a complex phenomenon that is influenced by many factors related to specific characteristics of the preterm infant, health care professional and parents. Despite numerous studies in various disciplines in the past decades, pain management in preterm infants remains a current concern due to the lack of effective interventions, prompting the need for further research. In order to adequately guide research, a theory is mandatory to define and circumscribe the variables that will be evaluated, the interpretation of results, and their implications. Currently, no theory of procedural pain in preterm infants has been identified in the scientific literature. This thesis aimed to develop, evaluate, and adapt a theory to procedural pain in preterm infants in order to provide a theoretical perspective on elements influencing the assessment and management of pain in this population. The development of the Pain Assessment and INterventions in Neonatology (PAIN-Neo) theory was based on a critical analysis of existing pediatric pain theories, as well as an exhaustive review of the literature to identify the variables involved in pain management of preterm infants at the empirical level. Moreover, the student researcher's knowledge and expertise in neonatology contributed to the theory by adding the interaction of the different categories of developmental care interventions. A critical realist philosophical perspective was chosen for the development of this theory, leading to the identification of the different Context-Mechanism-Outcomes configurations for each actor involved in the assessment and management of pain, i.e., the preterm infant, his or her parents, and the health professionals. The theory was evaluated with a systematic review with a meta-analysis including studies on preterm infants (n=1028) and a quantitative cross-sectional study of neonatal nurses (n=202). These studies validated some of the links established in the theory and provided an opportunity to revise it considering the empirical evaluation. 10 The PAIN-Neo theory developed in this thesis proposes an innovative vision of procedural pain management in the preterm infant for neonatal researchers and clinicians, by integrating the preterm infant, the healthcare professional and the parents, while considering the different individual and contextual factors influencing pain for these three actors. The PAIN-Neo theory can guide research involving one or more of these actors and can support the establishment of comprehensive clinical practice guidelines that reflect the complexity of pain management in preterm infants.

Introduction: Quality improvement (QI) encompasses a wide range of healthcare studies and activities with the common goal of improving patient outcomes, healthcare system performance, and professional development. QI is characterized by a diversity of definitions, stakeholders, clinical fields and study designs, which creates challenges for rigorous reporting and evaluation of these studies. Understanding and addressing the methodological issues that arise from conducting QI studies from multiple clinical disciplines is critical for generating good evidence for healthcare improvement to tackle health system challenges. Objectives: This thesis addressed three independent objectives: (i) Determine the quality of reporting of QI studies in neonatology. (ii) Compare different statistical methods that can be used to analyze data from a cluster randomized controlled trial with repeated measures data and examine how the estimate of intervention effects varies between these approaches. (iii) Determine the cost-effectiveness of providing timely surgery or timely rehabilitation for patients with hip fracture. Methods: Objective 1: We conducted a systematic survey of quality improvement studies in neonatology to examine the extent to which these publications adhered to SQUIRE 2.0, the guidelines for reporting studies that sought to improve the quality, safety, and value of healthcare. Using the same set of articles, we examined how various methodological attributes, such as stakeholder engagement, outcome measures, and statistical process controls, are reported in these studies. Objective 2: To compare the differences in the statistical estimates of intervention effects between linear mixed models and Generalized Estimating Equations, for the CP@Clinic Program cluster randomized RCT, which contains routinely collected monthly outcome data aggregated at the cluster level. Objective 3: We constructed a Markov cohort model to estimate the cost-effectiveness of receiving timely surgery within 24 hours of admission to the emergency department, receiving immediate admission to inpatient rehabilitation following acute care discharge, receiving both, or none. Results: Objective 1: In our assessment of reporting quality, we found that adherence to SQUIRE 2.0 guidelines was inadequate and that journals should endorse the SQUIRE 2.0 guideline for improvement publications to alleviate this issue. We found that process measures was the most frequently reported methodological attribute (89%), while stakeholder engagement with leadership (32%) or caregivers (10%) were infrequently reported or conducted. Objective 2: In comparing statistical methods for analyzing a cluster randomized controlled trial with correlated data, we found that it was critical to apply a correction to the variance estimator of generalized estimating equations to produce robust estimates of the intervention effects. Objective 3: In our economic evaluation, both timely surgery alone and the combination of timely surgery and timely rehabilitation yielded cost-effective improvements in the quality-adjusted life-years of patients with hip fracture. However, the combination of receiving timely surgery and timely rehabilitation requires a high willingness-to-pay threshold, above $128,000 per quality-adjusted life-years, to be considered cost-effective. Conclusions: Overall, understanding the state of reporting and the broad spectrum of methods and methodologic issues for evaluating quality improvement initiatives will advance its rigorous research, evaluation, reporting, and contribution towards informed decision-making for tackling pressing healthcare issues. / Thesis / Doctor of Philosophy (PhD) / Quality improvement (QI) is a field of healthcare research that can be defined in many ways, and research in this field is conducted by researchers from various medical disciplines. Consequently, challenges may arise in reporting and evaluating QI interventions. Thus, it is important to examine how QI interventions are reported in academic literature and the methods used to evaluate their effectiveness in improving health. The current thesis aims to address these issues through three independent objectives: (1) examine the details reported in QI studies in neonatology, (2) compare different statistical methods that can be used to analyze data from a community paramedicine cluster randomized controlled trial, and (3) investigate whether providing timely surgery and timely hospital-based rehabilitation is a cost-effective way to improve the quality of life of patients who have experienced hip fracture. The findings of these studies will provide insights into the challenges of reporting and evaluating QI interventions, and suggest ways to improve them.

Une femme à risque d’un accouchement prématuré vit un enjeu de santé très éprouvant et stressant ; elle sera souvent hospitalisée pour recevoir des traitements médicaux visant à prolonger la grossesse et améliorer le pronostic du bébé. Dans ce contexte, une consultation avec un néonatalogiste est demandée. Plusieurs associations professionnelles médicales ont émis des lignes directrices sur cette consultation, insistant sur le besoin d’informer les parents au sujet des complications potentielles de la prématurité pour leur enfant. Ces recommandations s’inspirent du point de vue médical, et très peu d’études ont examiné la perspective, les attentes et les besoins des parents à risque d’un accouchement prématuré. Ce projet de thèse a pour objectif de proposer un modèle de relation médecin-patient informé de la perspective maternelle de la consultation anténatale, pour développer une approche clinique répondant à leurs besoins. Afin d’examiner cette problématique de façon complète, un travail constant de va-et-vient a été effectué entre la recension de données empiriques et une réflexion normative bioéthique féministe. Un projet de recherche empirique a d’abord permis d’explorer les attentes et le vécu de ces femmes. Les participantes espéraient recevoir plus que de l’information sur les complications de la prématurité. Elles souhaitaient que le néonatologiste soit attentif à leur situation particulière et qu’il développe une relation de confiance avec elles, leur permettant d’explorer leurs futurs rôles de mères et les encourageant à formuler leurs propres questions. Le cadre théorique féministe d’autonomie relationnelle a ensuite permis de proposer une approche de soin qui sache répondre aux besoins identifiés par les patientes, tout en adressant des enjeux de pouvoir intrinsèques à la clinique, qui influencent la santé et l’autonomie de ces femmes. Cette approche insiste sur l’importance de la relation de soin en clinique, contrastant avec un modèle encourageant une vision réductrice de l’autonomie, dans laquelle un simple transfert de données scientifiques serait équivalent au respect de la norme médicolégale du consentement éclairé. Ce modèle relationnel propose des actions concrètes et pratiques, encourageant les cliniciens à entrer en relation avec chaque patiente et à considérer l’influence qu’ils exercent sur l’autonomie relationnelle de leurs patientes. / Women at risk of preterm labour experience a highly stressful situation for which they are often hospitalised to receive the medical care required to delay their baby’s birth or to improve his outcome. Professional medical associations have published guidelines encouraging consultations with a neonatologist in these contexts. These emphasize informing parents about prematurity’s potential complications and outcomes. However, they are based on expert medical opinions, and little is known about parents’ perspectives of the antenatal consultation for preterm labour. This thesis proposes to elaborate a clinical model of a physician-patient relationship, grounded in mothers’ experiences and expectations from the antenatal consultation for preterm labour. In order to offer a comprehensive analysis of this clinical and ethical issue, both empirical data and a normative feminist bioethical framework were used. An empirical quantitative research project was first conducted to explore women’s experiences and their expectations regarding the antenatal consultation. Participants hoped to receive more than information from the antenatal consultation for preterm labour. Indeed, they hoped the neonatologist would strive to understand their unique and distinctive situations. They wanted the physician to develop trusting relationships, in which they would be enabled to ask questions important to them and in which many topics could be discussed – such as their roles as mothers of a premature baby. A feminist theory of relational autonomy was then used to examine this data. An approach to care responsive to women’s experiences is suggested, which considers not only their individual needs, but which is also critical of the many power imbalances inherent to the clinical setting that influence patients’ health and autonomy. This approach emphasizes the importance of relationships in the physician-patient encounter; it offers a striking contrast to consultation models that endorse a minimal conception of patient autonomy, in which the simple transfer of medical knowledge and data is believed to uphold the legal doctrine of informed consent. This relational model suggests practical and tangible means for physicians to engage in relationships with their patients and to consider the influence they have on their patients’ relational autonomy.

PhD (Health Sciences) / Department of Advanced Nursing Science / Preterm birth is an unresolved health issue; globally it is the largest contributor to mortality among children under 5 years of age. Worldwide, approximately 9.6% of all births are preterm which the World Health Organization (WHO) recognizes as one of the top ten causes of neonatal deaths. The alarming rates of preterm births and deaths may be directly linked to the shortage of resources and an inadequate database of midwifery care guidelines for midwives in South Africa resulting in poor maternal care in public health. This study sought to develop midwifery practice guidelines to promote quality care of preterm babies in resource-limited obstetric units of the Limpopo Province of South Africa. The convergent parallel mixed method was used, explorative, descriptive and contextual qualitative design were run concurrently with the descriptive quantitative approach. For the qualitative design, non-probability purposive sampling was used to select midwives and managers from Limpopo Province. In-depth one-to-one interviews were conducted with 11 midwives and 4 managers. Tesch’s eight steps of open-coding was used to analyze qualitative data. Trustworthiness was ensured through credibility, confirmability, dependability and transferability. For the quantitative approach, 31 midwives and 24 managers completed the Likert scale questionnaire. The non-probability method was employed to select midwives and managers to make up a sample size of 55 participants. Reliability and validity of the instrument was ensured through extensive literature review and a pilot study. Data were analyzed with the IBM Statistical Package for the Social Sciences (SPSS) version 23.0. Both quantitative and qualitative data analysis yielded three themes as follows: the role of midwives in reduction of preterm births and deaths in obstetric units; challenges faced by midwives whilst executing their role during preconception, antenatal, labour and v puerperium period; support needed by midwives during provision of maternal and neonatal care to reduce preterm births and deaths. In the discussion of the findings, qualitative findings were supported by quantitative findings. The WHO model (PICOS & GRADES) was adapted in the development of the guidelines. The group then validated the guidelines using a closed-ended checklist to verify whether the guidelines were congruent with practice. The results were analyzed through simple descriptive statistics where the data were summarized using frequency / NRF