Characteristics of intervention studies on family-centred care in neonatal intensive care units: a scoping review of randomised controlled trials.

BACKGROUND: Different definitions of family-centred care (FCC) exist in the newborn setting, and many FCC interventions have been tested, while a comprehensive review synthesising characteristics of existing intervention studies is still lacking. OBJECTIVE: This review aims at summarising the characteristics of randomised controlled trials (RCTs) on FCC interventions in neonatal intensive care units. METHODS: We searched PubMed, Embase, Web of Science and the Cochrane Library up to 31 January 2022, and reference lists of included studies and other reviews. Interventions were grouped into five categories according to a previous Cochrane review: (1) family support, (2) educational, (3) communication, (4) environmental interventions and (5) family-centred policies. Subgroup analyses by time period (RCTs published before vs after 2016) and by country income (based on the World Bank Classification) were conducted. RESULTS: Out of 6583 retrieved studies, 146 RCTs met the eligibility criteria, with 53 (36.3%) RCTs published after 2016. Overall, 118 (80.8%) RCTs were conducted in high-income countries, 28 (19.1%) in middle-income countries and none in low-income countries. Only two RCTs were multicountry. Although mothers were the most frequent caregiver involved, fathers were included in 41 RCTs (28.1%). Very few studies were conducted in at-term babies (nine RCTs); siblings (two RCTs) and other family members (two RCTs), maternity care units (two RCTs). The role of health professionals was unclear in 65 (44.5%) RCTs. A large variety of intervention combinations was tested, with 52 (35.6%) RCTs testing more than 1 category of interventions, and 24 (16.4%) RCTs including all 5 categories. CONCLUSION: There is a large and rising number of RCTs on FCC interventions in neonatal intensive care units, with specific research gaps. The large variety of FCC interventions, their high complexity, the need to tailor them to the local context and major gaps in implementation suggest that implementation research is the current priority.

Family-centred care interventions in neonatal intensive care units: a scoping review of randomised controlled trials providing a menu of interventions, outcomes and measurement methods.

BACKGROUND: Benefits of different types of family-centred care (FCC) interventions in neonatal intensive care units (NICUs) have been reported. However, a comprehensive review of existing FCC intervention studies was lacking. OBJECTIVE: This review aimed at synthesising the characteristics of FCC interventions, related outcomes and measurement methods in randomised controlled trials (RCTs) in NICU, and providing menus of options to favour implementation and further research. METHODS: We searched PubMed, EMBASE, Web of Science and the Cochrane Library up to 31 January 2022. Interventions were mapped according to five categories as defined by a previous Cochrane review. We described outcome types, measurement populations, measurement methods and timelines. Subgroup analyses were also performed. RESULTS: Out of 6583 studies identified, 146 met eligibility criteria. Overall, 52 (35.6%) RCTs tested more than one category of intervention, with a large variety of combinations, with the most frequent category of intervention being the educational (138 RCTs, 94.5%). We identified a total of 77 different intervention packages, and RCTs comparing the same interventions were lacking. The 146 RCTs reported on 425 different outcomes, classified in 13 major categories with parental mental health (61 RCTs, 41.8% of total RCTs) being the most frequent category in parents, and neurobehavioural/developmental outcomes being the most frequent category in newborns (62 RCTs, 42.5%). For several categories of outcomes almost every RCT used a different measurement method. Educational interventions targeting specifically staff, fathers, siblings and other family members were lacking or poorly described. Only one RCT measured outcomes in health workers, two in siblings and none considered other family members. CONCLUSIONS: A large variety of interventions, outcomes and measurement methods were used in FCC studies in NICU. The derived menus of options should be helpful for researchers and policy makers to identify interventions most suitable in each setting and to further standardise research methods.

Parental stress, depression, anxiety and participation to care in neonatal intensive care units: results of a prospective study in Italy, Brazil and Tanzania.

BACKGROUND: Studies comparing the frequency of different mental health conditions across different settings and evaluating their association with parental participation in newborn care are lacking. We aimed at evaluating the frequency of parental stress, anxiety and depression, along with the level of participation in newborn care, among parents of newborns in Italy, Brazil and Tanzania. METHODS: Parental stress, anxiety, depression and participation in care were assessed prospectively in parents of newborns in eight neonatal intensive care units (NICUs) utilising: the Parental Stressor Scale in NICU (PSS:NICU); the Edinburgh Postnatal Depression Scale (EPDS) and EPDS-Anxiety subscale (EPDS-A); the Index of Parental Participation in NICU (IPP-NICU). Univariate and multivariate analyses were conducted. RESULTS: Study outcomes were assessed on 742 parents (Brazil=327, Italy=191, Tanzania=224). Observed scores suggested a very high frequency of stress, anxiety and depression, with an overall estimated frequency of any of the mental health condition of 65.1%, 52.9% and 58.0% in Brazil, Italy, Tanzania, respectively (p<0.001). EPDS scores indicating depression (cut-off: ≥13 for Brazil and Tanzania, ≥12 for Italy) were significantly more frequent in Tanzania (52.3%) when compared with either Brazil (35.8%) and Italy (33.3%) (p<0.001). Parental participation in care was also significantly higher in Tanzania (median IPP-NICU=24) than in the other two countries (median=21 for Brazil, 18 for Italy, p<0.001). Severe stress (PSS:NICU ≥4) was significantly more frequently reported in Brazil (22.6%), compared with Italy (4.7%) and Tanzania (0%, p<0.001). Factors independently associated with either parental stress, anxiety or depression varied by country, and a significant association with parental participation in care was lacking. CONCLUSIONS: Study findings suggest that parental stress, anxiety and depression are extremely frequent in NICUs in all countries despite diversity in the setting, and requiring immediate action. Further studies should explore the appropriate level of parental participation in care in different settings.

Long-term effects on growth in preterm and small for gestational age infants: A national birth cohort study.

BACKGROUND: Premature and small-for-gestational-age (SGA) infants tend to have long-term growth morbidities such as short stature, failure to thrive, and obesity. Although most of these infants show catch-up growth at 2-4 years of age, they are still more susceptible to childhood obesity and related metabolic disorders. Those who fail to achieve catch-up will suffer from pathological short stature and neurodevelopmental impairment through adulthood. This study aims to depict the growth pattern of premature or SGA infants and their growth morbidities in Taiwan. METHODS: Data were obtained from a nationally representative cohort of 24,200 pairs of postpartum women and newborns in the Taiwan Birth Cohort Study (TBCS), using structured questionnaire interviews. A total of 16,358 infants were included and three follow-up surveys were completed at 6, 18, and 36 months after the deliveries. We constructed growth curves to conduct an in-depth investigation into anthropometric data, applying a linear mixed model. Logistic regression was used to model the relevant outcomes, with adjustment for various potential confounding factors. RESULTS: Despite being born shorter and lighter, preterm and SGA infants generally showed catch-up growth and had no higher odds ratios (ORs) of developing short stature or failure to thrive compared to appropriate-for-gestational-age (AGA) term infants before 3 years of age. Preterm SGA infants, particularly females, had higher ORs for obesity at the 36-month follow-up. CONCLUSION: This is the first nationwide population-based study depicting the growth of SGA infants in Taiwan. The growth patterns of preterm and term SGA infants are different from those of preterm and term AGA infants. Further research is necessary to understand the growth trajectories of preterm and SGA infants and their associations with later diseases.

Differential Impact of Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit by Social Factors: A Post Hoc Subgroup Analysis.

Background: Barriers to attending family-centered rounds (FCR) exist for socially disadvantaged families. Using telehealth to conduct virtual FCR could potentially promote equitable parent/guardian FCR access. The objective of this work was to assess whether the effects of a virtual FCR intervention on parent FCR attendance varied by subgroups defined by social factors. Methods: We conducted a post hoc analysis of a randomized controlled trial of virtual FCR in the neonatal intensive care unit. Parents of intervention arm infants were invited to participate in virtual FCR plus usual care; control arm infants received usual care. Participants were analyzed according to the assigned group and by race/ethnicity, insurance, mother's education, and neighborhood health conditions. We used Poisson regression to estimate and compare FCR parent attendance rates. Heterogeneity of intervention effects was assessed using interaction terms to evaluate the relative benefit of the intervention in increasing parent FCR attendance. Results: We included all enrolled trial subjects (74 intervention, 36 control). Intervention arm infants had 3.36 (95% confidence interval [CI]: 2.66-4.23) times the FCR parent attendance rate of subjects in the control arm. Compared with the corresponding reference subgroup, intervention benefits were 2.15 times (95% CI: 1.30-3.56) better for racial/ethnic minorities, 3.08 times (95% CI: 1.59-5.95) better for those with private insurance, 2.68 times (95% CI: 1.12-6.40) better for those whose mother reported no college education, and 4.14 times (95% CI: 2.07-8.25) better for those from a neighborhood with worse health conditions. Conclusions: Virtual FCR improved parent FCR attendance overall, with even greater benefits for certain subgroups. Further research is needed to mitigate the differential benefit demonstrated for privately insured subjects.

A Rare Case of Congenital Generalized Lipodystrophy.

Congenital generalized lipodystrophy type 2 (CGL2) is a rare autosomal recessive disorder characterized by the near-total absence of adipose tissue, leading to various metabolic complications. We present the case of a one-year-old male who exhibited progressive abdominal distension from six months of age. Physical examination revealed distinctive features including triangular facies, hypertelorism, an emaciated appearance with absent buccal fat, and hepatosplenomegaly. Laboratory investigations showed elevated transaminases and a deranged lipid profile, while imaging confirmed hepatosplenomegaly without systemic anomalies. A liver biopsy indicated macrovesicular steatosis and impending cirrhosis. Genetic testing revealed a homozygous pathogenic variant in the BSCL2 gene (c.604C>T), confirming CGL2. The child is under regular follow-up, with genetic counseling provided to the parents. This case underscores the importance of early recognition, genetic diagnosis, and regular monitoring in managing this rare condition.

Clinical Management of Hydrops Fetalis in a Premature Neonate in India: A Case Report.

Hydrops fetalis has classically been defined as the presence of extracellular fluid in at least two fetal body compartments. This fluid collection includes skin edema (> 5 mm thickness), pericardial effusion, pleural effusion, and ascites. Here we present a case of a 29-year-old female with antenatally diagnosed severe hydrops fetalis which was postnatally successfully managed. Despite recent advances, immune hydrops are still a challenge for healthcare workers in third-world nations.

Optimization of manual ventilation quality using respiratory function monitoring in neonates: A two-phase intervention trial.

OBJECTIVE: The aim of this study was the evaluation of the impact of a respiratory function monitor (RFM, Neo100, Monivent AB, Gothenburg, Sweden) on the quality of ventilation in neonates. METHODS: This single-center two-phase intervention study was conducted at the Neonatal Intensive Care Unit and the delivery room of the Medical University of Vienna. Patients with clinical need for positive pressure ventilation were included in either of two consecutive study phases: (i) patients were ventilated with a hidden RFM (control) or (ii) visible RFM (intervention) during manual positive pressure ventilations. The duration of each phase was approximately six months. The primary outcome was the percentage of ventilations within a tidal volume range of 4-8 ml/kg (pVTe). RESULTS: A total of 90 patients (GA 22-66 weeks) were included. The primary outcome was significantly higher in the intervention group with a visible RFM (53.7%, SD 22.6) than in the control group without the monitor (37.3%, SD 20.5); (p < 0.001, mean difference [i.e., change in percentage points]: 16.95% CI: 7.4-35). In terms of secondary outcomes, excessive tidal volumes (>8ml/kg), potentially associated with an increased risk of brain injury, could be significantly reduced when a RFM was visible during ventilation (10.9% [IQR 26.4] vs. 29.5% [IQR 38.1]; p = 0.004). Furthermore, mask leakage could be significantly decreased (37.3% [SD 22.7] vs. 52.7% [SD 23.0]; p = 0.002). CONCLUSION: Our results suggest that the clinical application of a RFM for manual ventilation of preterm and term infants leads to a significant improvement in ventilation parameters.

Improving genetic testing utilization in a tertiary care neonatal intensive care unit through quality improvement.

There is an increasing recognition of the importance of diagnosing genetic conditions with an ever-growing list of genetic testing options. However, most providers do not have formal genetics training, which makes choosing the most appropriate test to order challenging. Our project sought to improve cytogenetic testing utilization in a tertiary care neonatal intensive care unit (NICU) through utilizing quality improvement techniques, specifically the Model for Improvement framework with rapid Plan-Do-Study-Act cycles. Our project utilized various interventions including the implementation of a NICU genetic testing algorithm. Interventions demonstrated improvement in all areas, specifically a 92% reduction in unnecessary cytogenetic testing with improvement in the diagnostic rate. Our work also resulted in a 59% decrease in charges with an estimated projected savings of $21,000 per year. Quality improvement can minimize redundancies and inefficiencies in genetic testing in a Level IV NICU in a large tertiary care children's hospital and result in substantial cost-savings.

Exploring adults' recollections of growing up with childhood motor difficulties: a qualitative study using systematic text condensation.

OBJECTIVE: To explore the ramifications of childhood motor difficulties, providing insights into their impact and consequences over time. DESIGN: A qualitative study using semistructured individual interviews. Data were analysed using systematic text condensation. SETTING: Neonatal intensive care recipients born at Uppsala University Children's Hospital, Uppsala, Sweden, between 1986 and 1989, were enrolled in a longitudinal follow-up study and subsequently interviewed in 2019-2020. PARTICIPANTS: 13 individuals in their early 30s, who met the criteria for developmental coordination disorder or performed below the 5th percentile on motor tests at 6.5 years of age, were interviewed. Those with co-occurring deficits in attention or social behavioural at age 6.5 were excluded. RESULTS: Two themes emerged: (1) lifelong challenges and (2) navigating the journey of motor difficulties: support, awareness and confidence. Five participants reported persistent motor difficulties. They adapted and integrated these challenges into their daily lives without feeling constrained. Parental support was crucial to their success, whereas support from schools was limited. CONCLUSION: Adults who faced motor difficulties in childhood developed effective coping strategies, overcame challenges and now lead fulfilling lives. The findings stress the importance of parental support and understanding, addressing contextual factors and fostering positive attitudes and supportive environments to enhance well-being and participation.

Tuberculosis preventive treatment in newborns.

OBJECTIVE: To describe the reported cases of newborns subjected to tuberculosis preventive treatment (TPT) in the state of Paraná, Brazil, and to evaluate the safety and effectiveness in preventing the progression of TB disease in this population. METHOD: Observational, descriptive case series, with secondary data. The characteristics of the participants were analyzed from the information systems of preventive treatment of TB (of Paraná), between 2009 and 2016. To evaluate which children had developed tuberculosis later or died, we used the data from the information systems of TB (in Brazil), and mortality (in Paraná), covering the years 2009 to 2018. RESULTS: A total of 24 children underwent TPT with the age at treatment onset ranging from 0 to 87 days (median: 23 days). In 95.8 %, the exposure occurred at home, and in 33.3 % of cases, the mother was the source of the infection. A total of 20.8 % of the children tested positive for tuberculosis test at 3 months of age, 83.3 % completed treatment, and 2 experienced adverse events (gastrointestinal issues). No children developed TB or died during the minimum of a 2-year evaluation period through the official databases. CONCLUSIONS: In this case series, the adherence to the plan was high, with few adverse events and 100 % protection against infection.

Causal evidence of the association between green and blue spaces (GBS) and maternal and neonatal health: a systematic review and meta-analysis protocol.

INTRODUCTION: Previous systematic reviews investigating the effects of green and blue space (GBS) on maternal and neonatal health have mainly focused on cross-sectional evidence, limiting potential causal inferences. The last review on the topic was published in January 2024. This review focused on residential greenness effects and neonatal health only but did not include other green/blue space measures, or maternal health outcomes. This review also only included papers published up to June 2023; discounting the 15 studies that have been published since. Thus, this study will capture the growing number of studies that generate causal evidence and aims to investigate the association between GBS and maternal and/or neonatal health. METHODS AND ANALYSIS: The study protocol was developed with reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This review will include study designs such as experiments, quasi-experiments, longitudinal studies and more. The study independent variable must be a GBS, green space and/or blue space measure. Eligible maternal health outcomes are those reported during pregnancy and up to 1 year after pregnancy. Neonatal health outcomes are limited to neonates no older than 28 days. A total of seven online databases will be searched: Medline, Scopus, Web of Science, PsycInfo, Embase, Environment Complete, and Maternity and Infant Care Database. Abstract and full-text screenings will be undertaken by three reviewers. Risk of bias assessment will be conducted based on the Risk of Bias in Non-randomized Studies-of Exposure framework.A narrative synthesis will be undertaken. If sufficiently comparable studies are identified, meta-analyses using random effects models will be conducted. We will explore heterogeneity using the I2 test. ETHICS AND DISSEMINATION: Ethical approval is not required as all the data will be derived from published primary studies that have already obtained ethical permissions. The findings will be disseminated through relevant conferences and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023396372.

Herpes simplex virus in infancy: Evaluation of national surveillance case capture.

AIM: As herpes simplex virus (HSV) in infancy is not a mandatory notifiable condition in Australia, completeness of ascertainment by the Australian Paediatric Surveillance Unit (APSU) has been difficult to evaluate to date. We evaluated case capture in Queensland (QLD) and Western Australia (WA) using statewide laboratory and clinical data and complementary surveillance data collected via the APSU. METHODS: HSV polymerase chain reaction positive results in infants (0-3 months) from 2007 to 2017 were obtained from statewide public pathology providers in QLD and WA. Clinical data were extracted from patient records and compared to APSU reported cases. RESULTS: A total of 94 cases of HSV disease in infancy (70 QLD; 24 WA) were identified from laboratory data sets, compared to 36 cases (26 QLD; 10 WA) reported to the APSU. In total there was 102 unique cases identified; 28 cases were common to both data sets (seven skin eye mouth (SEM) disease, 13 central nervous system (CNS) disease and eight disseminated disease). Active surveillance captured 35% (36/102) of cases overall including 74% (14/19) of CNS, 71% (10/14) of disseminated and 17% (12/69) of SEM disease cases, respectively. Surveillance reported cases had a higher case-fatality rate compared to those not reported (14% vs. 3%, P = 0.038). Neurological sequelae at discharge were comparable between the groups. CONCLUSION: Active surveillance captures one third of hospitalised HSV cases in QLD and WA, including the majority with severe disease. However, morbidity and mortality remain high. Future studies on HSV will rely on observational studies. Enhanced case ascertainment through combined laboratory and surveillance data is essential for better understanding and improving outcomes.

Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study.

OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants requiring NTI at the Children's Hospital of Philadelphia. INTERVENTIONS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location. MAIN OUTCOME MEASURE: VL NTI attempt success. RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009). CONCLUSION: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.

Predictors of successful neonatal intubation in inexperienced operators: a secondary, non-randomised analysis of the SHINE trial.

OBJECTIVE: Neonatal endotracheal intubation is a lifesaving but technically difficult procedure, particularly for inexperienced operators. This secondary analysis in a subgroup of inexperienced operators of the Stabilization with nasal High flow during Intubation of NEonates randomised trial aimed to identify the factors associated with successful intubation on the first attempt without physiological stability of the infant. METHODS: In this secondary analysis, demographic factors were compared between infants intubated by inexperienced operators and those intubated by experienced operators. Following this, for inexperienced operators only, predictors of successful intubation without physiological instability were analysed. RESULTS: A total of 251 intubations in 202 infants were included in the primary intention-to-treat analysis of the main trial. Inexperienced operators were more likely to perform intubations in larger and more mature infants in the neonatal intensive care unit where premedications were used. When intubations were performed by inexperienced operators, the use of nasal high flow therapy (nHF) and a higher starting fraction of inspired oxygen were associated with a higher rate of safe, successful intubation on the first attempt. There was a weaker association between premedication use and first attempt success. CONCLUSIONS: In inexperienced operators, this secondary, non-randomised analysis suggests that the use of nHF and premedications, and matching the operator to the infant and setting, may be important to optimise neonatal intubation success. TRIAL REGISTRATION NUMBER: ACTRN12618001498280.

Doctor-Parent Disagreement for Preterm Infants Born in the Grey Zone: Do Ethical Frameworks Help?

OBJECTIVE: To examine i) how ethical frameworks can be used in concrete cases of parent-doctors' disagreements for extremely preterm infants born in the grey zone to guide such difficult decision-making; and ii) what challenges stakeholders may encounter in using these frameworks. DESIGN: We did a case analysis of a concrete case of parent-doctor disagreement in the grey zone using two ethical frameworks: the best interest standard and the zone of parental discretion. RESULTS: Both ethical frameworks entailed similar advantages and challenges. They have the potential 1) to facilitate decision-making because they follow a structured method; 2) to clarify the situation because all relevant ethical issues are explored; and 3) to facilitate reaching an agreement because all parties can explain their views. We identified three main challenges. First, how to objectively evaluate the risk of severe disability. Second, parents' interests should be considered but it is not clear to what extent. Third, this is a value-laden situation and different people have different values, meaning that the frameworks are at least partially subjective. CONCLUSIONS: These challenges do not mean that the ethical frameworks are faulty; rather, they reflect the complexity and the sensitivity of cases in the grey zone.

Brain 3T magnetic resonance imaging in neonates: features and incidental findings from a research cohort enriched for preterm birth.

BACKGROUND AND OBJECTIVES: The survival rate and patterns of brain injury after very preterm birth are evolving with changes in clinical practices. Additionally, incidental findings can present legal, ethical and practical considerations. Here, we report MRI features and incidental findings from a large, contemporary research cohort of very preterm infants and term controls. METHODS: 288 infants had 3T MRI at term-equivalent age: 187 infants born <32 weeks without major parenchymal lesions, and 101 term-born controls. T1-weighted, T2-weighted and susceptibility-weighted imaging were used to classify white and grey matter injury according to a structured system, and incidental findings described. RESULTS: Preterm infants: 34 (18%) had white matter injury and 4 (2%) had grey matter injury. 51 (27%) infants had evidence of intracranial haemorrhage and 34 (18%) had punctate white matter lesions (PWMLs). Incidental findings were detected in 12 (6%) preterm infants. Term infants: no term infants had white or grey matter injury. Incidental findings were detected in 35 (35%); these included intracranial haemorrhage in 22 (22%), periventricular pseudocysts in 5 (5%) and PWMLs in 4 (4%) infants. From the whole cohort, 10 (3%) infants required referral to specialist services. CONCLUSIONS: One-fifth of very preterm infants without major parenchymal lesions have white or grey matter abnormalities at term-equivalent age. Incidental findings are seen in 6% of preterm and 35% of term infants. Overall, 3% of infants undergoing MRI for research require follow-up due to incidental findings. These data should help inform consent procedures for research and assist service planning for centres using 3T neonatal brain MRI for clinical purposes.