Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review.

BACKGROUND: A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units. METHODS: This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas. RESULTS: The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents' outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively. CONCLUSION: This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices. IMPACT: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.

Prioritizing family-centered developmental care: insights from parents of children with critical congenital heart disease: a qualitative study.

As survivors of early cardiac surgery are at high risk of neurodevelopmental impairments, systematic health observations of children with critical congenital heart disease (CCHD) throughout childhood are recommended to enable early diagnosis and offer interventions to optimize neurodevelopment. A qualitative study using thematic analysis was performed to explore parents' concerns, experiences, and needs regarding the development and received developmental care of their child (0-10 years) during hospital admission and beyond. Data were collected using semi-structured online interviews with 20 parents of children with CCHD. Four major themes were identified: (1) "impact of diagnosis and disease on the family-system," (2) "parental concerns from diagnoses and beyond," (3) "the need for information," and (4) "the need for individualized and family-centered care." The main themes can be divided into 13 sub-themes as impact, concerns, and needs are influenced by various impactful moments from diagnosis and afterwards.     Conclusion: This study confirms the importance of early identification of neurodevelopmental problems by experienced healthcare professionals, especially in the early years when parental expectations and concerns about their child's neurodevelopment are lower. A tailor-made family-centered follow-up program should be offered, which pays attention to both the neurodevelopment of patients with CCHD as well as the mental wellbeing of the entire family system. Furthermore, an online portal is recommended with a variety of reliable, controlled, understandable information from which parents can obtain the desired information to understand better the consequences of specific heart condition and to provide their child with the best possible guidance. What is Known: • Survivors of early cardiac surgery are at high risk of neurodevelopmental impairments; systematic health observations of children with CCHD throughout childhood are strongly recommended. What is New: • Parents need a tailor-made family-centered follow-up program, which pays attention to both the neurodevelopment of patients with CCHD as well as the mental wellbeing of the entire family system. • An online portal offering diverse, trustworthy information and sources would effectively meet parents' needs by providing accessible insights into the potential consequences of specific heart conditions and guiding them in supporting their child optimally.

Evaluating the Baby@Home program: Early discharge strategies for (pre)term infants are safe and benefit health outcomes.

AIM: Prolonged hospitalisation in the neonatal intensive care unit (NICU) can emotionally tax newborn infants and their families, resulting in developmental adversities and inadequate parent-infant bonding. This study aimed to assess the feasibility and value of the Baby@Home program in reducing prolonged hospital stays. METHODS: This is a retrospective cohort study of 26 infants from a tertiary neonatology department, using qualitative data (gathered through interviews with parents (n = 15) and professionals (n = 5)) and quantitative data (retrieved from medical records and the Luscii application). RESULTS: Our study included 26 newborn infants. 76% were premature, born at an average term of 35 weeks and 2 days. During the study period, all infants thrived, and only two adverse events occurred (an allergic reaction and respiratory incident necessitating readmission). Interviews were conducted based on six major themes concerning the feasibility and value of the program. Despite the challenges of application utilisation, the program's overall value was evident. CONCLUSION: The Baby@Home program effectively facilitated early discharge, promoted family reunification, and yielded favourable safety and health outcomes. Innovative solutions such as Baby@Home have the potential to pave the way for more sustainable and patient-centred care models.

The psychosocial impact of male infertility on men undergoing ICSI treatment: a qualitative study.

BACKGROUND: Male infertility is in 20-70% of cases the cause of a couple's infertility. Severe forms of male infertility are best treated with Intracytoplasmic Sperm Injection (ICSI). The psychosocial impact of infertility and ICSI on men is unclear because the focus is socially, clinically, and scientifically on women. However, there is evidence that it can affect the psychological well-being of men, but these studies are mainly quantitative. Qualitative research needed to explore the experiences of infertile men in-depth is limited. Therefore, the objective of this study was to clarify the psychosocial consequences of male infertility on men undergoing ICSI to understand their experiences with reproduction problems more comprehensively. METHODS: In this generic qualitative study, men who were undergoing or had undergone ICSI after a male factor infertility diagnosis were included. A purposive sample with maximum variation was sought in a fertility clinic of one university medical centre in the Netherlands. Data were collected through individual face-to-face semi-structured interviews. Thematic analysis was used to identify themes from the data. RESULTS: Nineteen Dutch men were interviewed. The mean duration of the interviews was 90 min. An everyday contributing backpack was identified as the main theme, as men indicated that they always carried the psychosocial consequences of infertility and ICSI with them. Different world perspective, Turbulence of emotions, Changing relation, and Selective sharing were the psychosocial consequences that men were most affected by. Moreover, men indicated that they were Searching for contribution during ICSI because the focus was entirely on the woman. CONCLUSION: Men with male infertility experience psychosocial problems due to infertility and ICSI treatment. Healthcare professionals need to recognize the impact of infertility on men and create room for a role for them during ICSI.

Infertility, defined as not being able to get pregnant after at least 1 year of unprotected sex, is often caused by a male problem. ICSI (Intracytoplasmic Sperm Injection) is the suggested treatment for couples dealing with male infertility. During this treatment, in the laboratory, a single sperm is injected into an egg of the woman. This procedure can create an embryo that can be transferred into the woman's uterus. Women, unlike men, have to undergo many medical examinations and treatments during ICSI which can cause changes in their mental well-being. How and whether men's psychological and social well-being can be affected by infertility and ICSI is unclear. Therefore, by interviewing 19 Dutch men dealing with male infertility who were undergoing or had undergone ICSI, an attempt was made to better understand reproductive problems from their perspective. The interviews were all face-to-face and had a mean duration of 90 min. We found that men experienced various psychosocial consequences from infertility and ICSI: they started looking at the world differently, their relationship with their partner changed, emotions alternated, information sharing became selective and they were searching for contribution. The main theme: An everyday contributing backpack was identified, as men indicated that they always carried these psychosocial consequences with them in their daily lives. From this qualitative research, it has become clear that men dealing with male infertility experience psychosocial problems due to infertility and ICSI treatment. Healthcare professionals need to recognize the impact of infertility on men and create room for them.

The effects of percutaneous branch pulmonary artery interventions on exercise capacity, lung perfusion, and right ventricular function in biventricular CHD: a systematic review.

BACKGROUND: Branch pulmonary artery stenosis is common after surgical repair in patients with biventricular CHD and often requires reinterventions. However, (long-term) effects of percutaneous branch pulmonary artery interventions on exercise capacity, right ventricular function, and lung perfusion remain unclear. This review describes the (long-term) effects of percutaneous branch pulmonary artery interventions on exercise capacity, right ventricular function, and lung perfusion following PRISMA guidelines. METHODS: We performed a systematic search in PubMed, Embase, and Cochrane including studies about right ventricular function, exercise capacity, and lung perfusion after percutaneous branch pulmonary artery interventions. Study selection, data extraction, and quality assessment were performed by two researchers independently. RESULTS: In total, 7 eligible studies with low (n = 2) and moderate (n = 5) risk of bias with in total 330 patients reported on right ventricular function (n = 1), exercise capacity (n = 2), and lung perfusion (n = 7). Exercise capacity and lung perfusion seem to improve after a percutaneous intervention for branch pulmonary artery stenosis. No conclusions about right ventricular function or remodelling, differences between balloon and stent angioplasty or specific CHD populations could be made. CONCLUSION: Although pulmonary artery interventions are frequently performed in biventricular CHD, data on relevant outcome parameters such as exercise capacity, lung perfusion, and right ventricular function are largely lacking. An increase in exercise capacity and improvement of lung perfusion to the affected lung has been described in case of mild to more severe pulmonary artery stenosis during relatively short follow-up. However, there is need for future studies to evaluate the effect of pulmonary artery interventions in various CHD populations.

Neurodevelopmental consequences of preterm punctate white matter lesions: a systematic review.

OBJECTIVES: To evaluate punctate white matter lesion (PWML) influence in preterm infants on the long-term neurodevelopmental outcome (NDO). METHODS: PubMed and EMBASE were searched from January 1, 2000, to May 31, 2021. Studies were included in which PWML in preterm infants on MRI around term-equivalent age (TEA) and NDO at ≥12 months were reported. Study and patient characteristics and NDO on motor, cognitive, and behavioral domains were extracted. The quality of studies was assessed using the Cochrane-approved Quality in Prognosis Studies tool. RESULTS: This analysis included nine studies with a total of 1655 patients. Mean incidence of isolated PWML was 22.1%. All studies showed a relationship between PWML and motor delay. Two studies found a significant correlation between cognitive and behavioral outcomes and PWML. Number and PWML location are related to severity and impairment types. LIMITATIONS: PWML were not always separately described from generalized WMI, only studies with imaging around TEA were included, and studies were heterogenic in design and quality. CONCLUSIONS: PWML is common in preterm infants and predictive of adverse NDO, in particular on motor outcomes and less on cognitive and behavioral outcomes. The type and severity of impairments are related to the number and location of PMWL. IMPACT: PWML is common in preterm infants and seems predictive of adverse NDO. DWI and SWI MRI sequences are informative because the different patterns suggest a difference in the underlying pathology. The type and severity of impairments are related to the number and location of PMWL. Our review can inform clinicians and parents about the NDO of preterm infants with a diagnosis of PWML. Prospective neuroimaging case-control cohort studies are recommended.

How to support children to develop and express their coping preferences around minor invasive medical procedures: children's and parents' perspectives.

Invasive medical procedures in hospitals are major sources of stress in children, causing pain and fear. Non-pharmacological interventions are indispensable in effective pain and fear management. However, these interventions must be personalized to be effective. This qualitative study aims to gain insight into children's and parents' experiences, needs, and wishes related to supporting children to develop and express their coping preferences for dealing with pain and fear during minor invasive medical procedures in order to decrease pain and fear. A qualitative study using thematic analysis was performed. Data were collected through semi-structured interviews with children and parents who had undergone at least five minor invasive medical procedures in the last year. Nineteen children (8-18 years) and fourteen parents were interviewed individually. The experiences, needs, and wishes expressed in the interviews could be classified into one overarching theme, that of the personal process, and two content-related sub-themes: feeling trust and gaining control. The personal process was divided into two different phases, that of developing and of expressing coping preferences. Children and parents both reported it as a continuous process, different for every child, with their own unique needs. Children and parents expected personalized attention and tailored support from professionals.     Conclusion: Professionals must combine clinical skills with child-tailored care. In the process of searching for and communicating about coping preferences, children's unique needs and personal boundaries will thereby be respected. This gives children and parents increased trust and control during invasive medical procedures. What is Known: • Untreated pain and stress caused by medical procedures can have severe and important short- and long-term consequences for children. Personalized non-pharmacological interventions are an essential element of procedural pain management. What is New: • A personalized coping strategy is important for children when undergoing medical procedures. Each individual child has a personal way of expressing their own coping strategy. Children and their parents need information and the space to develop and express their individual coping preferences. • Children and parents expect to receive child-tailored care from professionals including respect for their own, unique needs and boundaries. Professionals should build trustful relationships and provide appropriately tailored autonomy around medical procedures.

Evaluation of Sleep Practices and Knowledge in Neonatal Healthcare.

BACKGROUND: Developmental care is designed to optimize early brain maturation by integrating procedures that support a healing environment. Protecting preterm sleep is important in developmental care. However, it is unclear to what extent healthcare professionals are aware of the importance of sleep and how sleep is currently implemented in the day-to-day care in the neonatal intensive care unit (NICU). PURPOSE: Identifying the current state of knowledge among healthcare professionals regarding neonatal sleep and how this is transferred to practice. METHODS: A survey was distributed among Dutch healthcare professionals. Three categories of data were sought, including (1) demographics of respondents; (2) questions relating to sleep practices; and (3) objective knowledge questions relating to sleep physiology and importance of sleep. Data were analyzed using Spearman's rho test and Cramer's V test. Furthermore, frequency tables and qualitative analyses were employed. RESULTS: The survey was completed by 427 participants from 34 hospitals in 25 Dutch cities. While healthcare professionals reported sleep to be especially important for neonates admitted in the NICU, low scores were achieved in the area of knowledge of sleep physiology. Most healthcare professionals (91.8%) adapted the timing of elective care procedures to sleep. However, sleep assessments were not based on scientific knowledge. Therefore, the difference between active sleep and wakefulness may often be wrongly assessed. Finally, sleep is rarely discussed between colleagues (27.4% regularly/always) and during rounds (7.5%-14.3% often/always). IMPLICATIONS: Knowledge about sleep physiology should be increased through education among neonatal healthcare professionals. Furthermore, sleep should be considered more often during rounds and handovers.

Sensory-based interventions in the NICU: systematic review of effects on preterm brain development.

BACKGROUND: Infants born preterm are known to be at risk for abnormal brain development and adverse neurobehavioral outcomes. To improve early neurodevelopment, several non-pharmacological interventions have been developed and implemented in the neonatal intensive care unit (NICU). Sensory-based interventions seem to improve short-term neurodevelopmental outcomes in the inherently stressful NICU environment. However, how this type of intervention affects brain development in the preterm population remains unclear. METHODS: A systematic review of the literature was conducted for published studies in the past 20 years reporting the effects of early, non-pharmacological, sensory-based interventions on the neonatal brain after preterm birth. RESULTS: Twelve randomized controlled trials (RCT) reporting short-term effects of auditory, tactile, and multisensory interventions were included after the screening of 1202 articles. Large heterogeneity was identified among studies in relation to both types of intervention and outcomes. Three areas of focus for sensory interventions were identified: auditory-based, tactile-based, and multisensory interventions. CONCLUSIONS: Diversity in interventions and outcome measures challenges the possibility to perform an integrative synthesis of results and to translate these for evidence-based clinical practice. This review identifies gaps in the literature and methodological challenges for the implementation of RCTs of sensory interventions in the NICU. IMPACT: This paper represents the first systematic review to investigate the effect of non-pharmacological, sensory-based interventions in the NICU on neonatal brain development. Although reviewed RCTs present evidence on the impact of such interventions on the neonatal brain following preterm birth, it is not yet possible to formulate clear guidelines for clinical practice. This review integrates existing literature on the effect of sensory-based interventions on the brain after preterm birth and identifies methodological challenges for the conduction of high-quality RCTs.

Neonates and COVID-19: state of the art : Neonatal Sepsis series.

The SARS-CoV-2 pandemic has had a significant impact worldwide, particularly in middle- and low-income countries. While this impact has been well-recognized in certain age groups, the effects, both direct and indirect, on the neonatal population remain largely unknown. There are placental changes associated, though the contributions to maternal and fetal illness have not been fully determined. The rate of premature delivery has increased and SARS-CoV-2 infection is proportionately higher in premature neonates, which appears to be related to premature delivery for maternal reasons rather than an increase in spontaneous preterm labor. There is much room for expansion, including long-term data on outcomes for affected babies. Though uncommon, there has been evidence of adverse events in neonates, including Multisystem Inflammatory Syndrome in Children, associated with COVID-19 (MIS-C). There are recommendations for reduction of viral transmission to neonates, though more research is required to determine the role of passive immunization of the fetus via maternal vaccination. There is now considerable evidence suggesting that the severe visitation restrictions implemented early in the pandemic have negatively impacted the care of the neonate and the experiences of both parents and healthcare professionals alike. Ongoing collaboration is required to determine the full impact, and guidelines for future management. IMPACT: Comprehensive review of current available evidence related to impact of the COVID-19 pandemic on neonates, effects on their health, impact on their quality of care and indirect influences on their clinical course, including comparisons with other age groups. Reference to current evidence for maternal experience of infection and how it impacts the fetus and then neonate. Outline of the need for ongoing research, including specific areas in which there are significant gaps in knowledge.

Brain proton magnetic resonance spectroscopy and neurodevelopment after preterm birth: a systematic review.

BACKGROUND: Preterm infants are at risk of neurodevelopmental impairments. At present, proton magnetic resonance spectroscopy (1H-MRS) is used to evaluate brain metabolites in asphyxiated term infants. The aim of this review is to assess associations between cerebral 1H-MRS and neurodevelopment after preterm birth. METHODS: PubMed and Embase were searched to identify studies using 1H-MRS and preterm birth. Eligible studies for this review included 1H-MRS of the brain, gestational age ≤32 weeks, and neurodevelopment assessed at a corrected age (CA) of at least 12 months up to the age of 18 years. RESULTS: Twenty papers evaluated 1H-MRS in preterm infants at an age between near-term and 18 years and neurodevelopment. 1H-MRS was performed in both white (WM) and gray matter (GM) in 12 of 20 studies. The main regions were frontal and parietal lobe for WM and basal ganglia for GM. N-acetylaspartate/choline (NAA/Cho) measured in WM and/or GM is the most common metabolite ratio associated with motor, language, and cognitive outcome at 18-24 months CA. CONCLUSIONS: NAA/Cho in WM assessed at term-equivalent age was associated with motor, cognitive, and language outcome, and NAA/Cho in deep GM was associated with language outcome at 18-24 months CA. IMPACT: In preterm born infants, brain metabolism assessed using 1H-MRS at term-equivalent age is associated with motor, cognitive, and language outcomes at 18-24 months. 1H-MRS at term-equivalent age in preterm born infants may be used as an early indication of brain development. Specific findings relating to NAA were most predictive of outcome.

Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials.

BACKGROUND: The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents. METHODS: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered. RESULTS: Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain. CONCLUSIONS: This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation. IMPACT: This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.

Getting a grip in the middle of chaos: Preparing for preterm parenthood during a high-risk pregnancy - Parental experiences and needs.

AIM: Admitting an infant to a neonatal intensive care unit (NICU) is stressful for parents. A great source of stress is the loss of their desired parental role. This study explores parents' experiences and needs during a high-risk pregnancy in preparation for their role as parents of a preterm infant. METHODS: An exploratory qualitative study was conducted among parents with a preterm infant admitted to two level-III NICUs in the Netherlands. A thematic analysis was performed. RESULTS: Nineteen interviews were conducted with parents of preterm infants (26-34 weeks gestational age). Getting a grip in the middle of chaos was identified as the central theme. In the pre-admission phase, coping with potential preterm parenthood was a theme, with coping strategies as subthemes that changed over time from avoidance to being ready to parent a preterm infant. The theme envisioning the NICU emerged in the NICU admission phase, with subthemes preterm care journey and opportunities for involvement fostering parental empowerment. CONCLUSION: Timing and content of information about a parental role in the NICU should be tailored to the individual expectant parent. A customisable intervention bundle may provide a vision of the NICU and the parents' active role in care.

Exploring key elements of approaches that support childrens' preferences during painful and stressful medical procedures: A scoping review.

PROBLEM: Children undergoing medical procedures can experience pain and distress. While numerous interventions exist to mitigate pain and distress, the ability to individualize the intervention to suit the needs and preferences of individual children is emerging as an important aspect of providing family-centered care and shared decision making. To date, the approaches for supporting children to express their preferences have not been systematically identified and described. A scoping review was conducted to identify such approaches and to describe the elements that are included in them. ELIGIBILITY CRITERIA: Studies that (a) described approaches with the aim to support children to express their coping preferences during medical procedures; (b) included the option for children to choose coping interventions; (c) included a child (1--18 years). SAMPLE: Searches were conducted in December 2019 and November 2020 in the following databases: Cinahl, Embase, PubMed and Psycinfo. RESULTS: Thirteen studies were identified that included six distinct approaches. Four important key elements were identified: 1) Aid to express preferences or choice, 2) Information Provision, 3) Assessment of feelings/emotions, 4) Feedback/Reflection and Reward. CONCLUSIONS: Identified approaches incorporate components of shared decision-making to support children in expressing their preferences during medical procedures and treatments. IMPLICATIONS: Children undergoing medical procedures can be supported in expressing their coping needs and preferences by using components of shared decision-making.

Parental experiences of their infant's hospital admission undergoing cardiac surgery: A systematic review.

AIM: To explore parents' experiences of parenting a child hospitalised with congenital heart disease (CHD) and undergoing surgery. METHODS: Five electronic databases were systematically searched for articles describing the experiences of parents with a child with a CHD. A thematic analysis approach was used to identify the most common themes. RESULTS: A total of 188 articles were identified. Eight studies were included in the review. Four themes emerged, including balancing the parental role, experiencing anticipatory grief, decreasing parental stress using coping strategies and professional support. CONCLUSION: Having a child with CHD undergoing heart surgery is a stressful experience due to, among other things, the different situation-related parenting role during the hospital stay and feelings of anticipatory grief. Healthcare professionals in the PICU have an essential role in supporting parents and understanding the needs that are crucial for the parents in order to provide better support and reduce stress and anxiety. More qualitative research regarding the pathway from the prenatal diagnosis through the early childhood period is warranted.

Factors associated with successful rehabilitation in older adults: A systematic review and best evidence synthesis.

Purpose; Returning to community living is an indicator for successful rehabilitation in older adults admitted to geriatric rehabilitation. Predicting successful rehabilitation could contribute to the deployment of early discharge planning, and leads to a more custom-made rehabilitation trajectory. This review aims to present an overview of factors associated with successful rehabilitation following inpatient geriatric rehabilitation. Method; A systematic literature review was conducted in PubMed, CINAHL and Embase. Extracted factors were analysed via Bakker's five levels of evidence. Results; Nine studies with methodological quality of good to moderate were included. For 13 of the 18 extracted factors, limited (n=3), moderate (n=5) and conflicting (n=5) evidence found a significant association. Conclusions; Caregiver, comorbidities, motor-function, nutritional status, time from onset are significantly related to successful rehabilitation. These factors could support healthcare professionals to indicate successful rehabilitation at admission and contributes to deployment of early discharge planning and development of more custom-made rehabilitation trajectories.

Parents' experiences of VOICE: A novel support programme in the NICU.

BACKGROUND: Admission of an infant to a neonatal intensive care unit (NICU) is often a stressful experience for parents and can be associated with feelings of inadequacy to fulfil the desirable parental role. The values, opportunities, integration, control, and evaluation (VOICE) programme was developed to engage parents in care, to decrease stress, and to increase empowerment. AIM: To explore the experiences of parents regarding involvement in the VOICE programme during admission of their infant to the NICU. DESIGN: The VOICE programme includes at least five personal structured meetings between parents, nurses, and other health care professionals throughout the pathway from birth, NICU, and follow up. A qualitative design was adopted using semi-structured interviews. Interviews with 13 parents of 11 infants born at <27 weeks' gestational age were conducted: nine mothers and two couples of father and mother. Thematic analysis was deployed. RESULTS: The findings have been described in one overarching theme: "parental empowerment." Parents felt strengthened and were empowered in the development of their role as primary caretaker by the VOICE programme. The parental empowerment theme emerged from four related interpretive themes that were derived: (a) involvement in care, (b) personalized information and communication, (c) transition to a parental role, and (d) emotional support. CONCLUSION: The VOICE programme can be a structured approach used to implement family support in a NICU to empower parents to become a partner in the care of their infant and feel confident. RELEVANCE TO CLINICAL PRACTICE: This study encourages health care professionals to provide parental support through a structured intervention programme, which contributes to the empowerment of parents in the NICU and encouraged them to participate in care and decision-making.

Challenges in developing a consensus definition of neonatal sepsis.

Sepsis remains a leading cause of morbidity and mortality in the neonatal population, and at present, there is no unified definition of neonatal sepsis. Existing consensus sepsis definitions within paediatrics are not suited for use in the NICU and do not address sepsis in the premature population. Many neonatal research and surveillance networks have criteria for the definition of sepsis within their publications though these vary greatly and there is typically a heavy emphasis on microbiological culture. The concept of organ dysfunction as a diagnostic criterion for sepsis is rarely considered in neonatal literature, and it remains unclear how to most accurately screen neonates for organ dysfunction. Accurately defining and screening for sepsis is important for clinical management, health service design and future research. The progress made by the Sepsis-3 group provides a roadmap of how definitions and screening criteria may be developed. Similar initiatives in neonatology are likely to be more challenging and would need to account for the unique presentation of sepsis in term and premature neonates. The outputs of similar consensus work within neonatology should be twofold: a validated definition of neonatal sepsis and screening criteria to identify at-risk patients earlier in their clinical course. IMPACT: There is currently no consensus definition of neonatal sepsis and the definitions that are currently in use are varied.A consensus definition of neonatal sepsis would benefit clinicians, patients and researchers.Recent progress in adults with publication of Sepsis-3 provides guidance on how a consensus definition and screening criteria for sepsis could be produced in neonatology.We discuss common themes and potential shortcomings in sepsis definitions within neonatology.We highlight the need for a consensus definition of neonatal sepsis and the challenges that this task poses.

When a child dies: a systematic review of well-defined parent-focused bereavement interventions and their alignment with grief- and loss theories.

BACKGROUND: The availability of interventions for bereaved parents have increased. However, most are practice based. To enhance the implementation of bereavement care for parents, an overview of interventions which are replicable and evidence-based are needed. The aim of this review is to provide an overview of well-defined bereavement interventions, focused on the parents, and delivered by regular health care professionals. Also, we explore the alignment between the interventions identified and the concepts contained in theories on grief in order to determine their theoretical evidence base. METHOD: A systematic review was conducted using the methods PALETTE and PRISMA. The search was conducted in MEDLINE, Embase, and CINAHL. We included articles containing well-defined, replicable, paediatric bereavement interventions, focused on the parent, and performed by regular health care professionals. We excluded interventions on pathological grief, or interventions performed by healthcare professionals specialised in bereavement care. Quality appraisal was evaluated using the risk of bias, adapted risk of bias, or COREQ. In order to facilitate the evaluation of any theoretical foundation, a synthesis of ten theories about grief and loss was developed showing five key concepts: anticipatory grief, working models or plans, appraisal processes, coping, and continuing bonds. RESULTS: Twenty-one articles were included, describing fifteen interventions. Five overarching components of intervention were identified covering the content of all interventions. These were: the acknowledgement of parenthood and the child's life; establishing keepsakes; follow-up contact; education and information, and; remembrance activities. The studies reported mainly on how to conduct, and experiences with, the interventions, but not on their effectiveness. Since most interventions lacked empirical evidence, they were evaluated against the key theoretical concepts which showed that all the components of intervention had a theoretical base. CONCLUSIONS: In the absence of empirical evidence supporting the effectiveness of most interventions, their alignment with theoretical components shows support for most interventions on a conceptual level. Parents should be presented with a range of interventions, covered by a variety of theoretical components, and aimed at supporting different needs. Bereavement interventions should focus more on the continuous process of the transition parents experience in readjusting to a new reality. TRIAL REGISTRATION: This systematic review was registered in Prospero (registration number: CRD42019119241).

Perspectives of parents and nurses on the content validity of the Family Empowerment Scale for parents of children with a chronic condition: A mixed-methods study.

BACKGROUND: Insight into parental empowerment is important to understanding the impact of health care policy and to supporting and strengthening parents in the care of their child. The Family Empowerment Scale (FES) is a valid 24-item instrument that measures parental empowerment. It was originally developed for parents of children with emotional disabilities. It has been translated from English into Dutch. Before using the translated FES in another context, the aim of this study was to assess the content validity of the Dutch FES in the context of children with a chronic condition in a children's hospital, according to parents and nurses. METHOD: This content validity study has a convergent, mixed-methods design. The content validity index was used to examine the relevance, according to 22 parents and 12 nurses quantitatively, on a scale and item level. The qualitative part assessed the comprehensiveness and comprehension of the FES through cognitive interviewing with eight parents and four nurses. The results of both analyses were converged to determine content validity. RESULTS: The scale-content validity index was 0.88; three items scored < 0.78 on the item level. For 10 (of 24) items, issues were noticed about the tone and clarity of wording. Participants considered the FES to be not only an instrument of research but also an instrument that could be used to give insight into the personal degree of parental empowerment. CONCLUSION: The content validity of the Dutch FES for parents of children with a chronic condition can be considered sufficient. Resolving some minor translation issues in some of the items is advised. The FES can be used in further research to examine the value of the FES in health care services, aiming to support the needs of parents and to increase their empowerment.