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BACKGROUND: There is an increased risk of venous thromboembolism (VTE) among neonates due to their unique hemostatic system. However, there is lack of approved treatment options for VTE in neonatal population. Importantly, dalteparin, a low molecular weight heparin approved for pediatric VTE in children ≥1 month of age, has also been used for the treatment of neonatal VTE. Based on the request from the Food and Drug Administration, this retrospective study aimed to characterize the safety, clinical effects, and dosing of dalteparin for treatment of VTE among neonates. PROCEDURE: Data from electronic medical records for neonates (born ≥35 weeks of gestation) treated with dalteparin for VTE between January 2010 and December 2021 were collected. The data assessed included bleeding and deterioration in hematological biomarkers among other adverse events, changes in relevant factor antifactor Xa (anti-Xa) levels and VTE status, and dosing of dalteparin and corresponding anti-Xa assay levels. RESULTS: Sixteen neonates from five participating sites in the United Kingdom were included. There were no bleeding events or deaths. Only one serious adverse event of hypoglycemic brain injury (unrelated to dalteparin) was documented in a patient with a history of hyperinsulinism. Median (range) daily dose of dalteparin at initiation was 309 (297-314) IU/kg. Eight of 16 neonates achieved therapeutic anti-Xa level, including two patients who did so after the first dose. CONCLUSIONS: Dalteparin treatment in neonates raised no major safety concerns. Larger cohort studies may help provide further insights on clinical effects of dalteparin for neonatal VTE.
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INTRODUCTION: Neonatal care is complex, involving multiple people and technologies within a community of care. When preterm babies are cared for far from home and/or transferred between units, the whole community of care (and particularly parent participation) is disrupted. Although previous studies have captured subjective experiences of parents, there has been little research exploring the material practices undertaken by parents as a consequence of place-of-care decisions, or the social organisation of those practices. METHODS: As part of a wider study exploring optimal place-of-care, semistructured interviews were conducted between July 2018 and October 2019 with 48 parents (36 families) with one or more preterm babies (born at 27-31 weeks gestation) cared for in a neonatal unit in the last 12 months. FINDINGS: We highlight parents' labour-intensive and stressful work to: (1) parent in the neonatal care community (an oversight role that goes beyond contemporary notions of 'involvement'); (2) create continuity amid place-of-care disruptions; and (3) adapt to the managerial logics of neonatal care settings. Our analysis focuses on the work generated by managerial systems that organise place-of-care decision-making and other efficiency-focused practices. Parents are absorbed into negotiating institutional systems and diverted from routine parenting activities. CONCLUSION: Those involved in the organisation and management of neonatal care should take account of how managerial systems impact parents' workload, ability to participate in their baby's community of care and, ultimately, on the wellbeing and development of babies and their families. PATIENT OR PUBLIC CONTRIBUTION: The OPTI-PREM study embedded parents' experiences of neonatal care into the research, through a discrete workstream that employed qualitative methodology to capture parents' experiences-as reported in this paper. The OPTI-PREM project was also supported by a Bliss volunteer parent panel, which was involved in designing and overseeing the research. Bliss 'champion[s] the right for every baby born premature or sick to receive the best care by supporting families, campaigning for change and supporting professionals and enabling life-changing research' (https://www.bliss.org.uk/about-us/about-bliss). A representative of Bliss is a co-author of this manuscript, and a parent representative (named in the Acknowledgements) provided feedback during its preparation.
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Recém-Nascido Prematuro , Entrevistas como Assunto , Poder Familiar , Pais , Pesquisa Qualitativa , Humanos , Pais/psicologia , Feminino , Recém-Nascido , Masculino , Poder Familiar/psicologia , Adulto , Unidades de Terapia Intensiva NeonatalRESUMO
Almost 30% of live births in England and Wales occur late preterm or early term (LPET) and are associated with increased risks of adverse health outcomes throughout the lifespan. However, very little is known about the decision-making processes concerning planned LPET births or the involvement of parents in these. This aim of this paper is to review the evidence on parental involvement in obstetric decision-making in general, to consider what can be extrapolated to decisions about LPET delivery, and to suggest directions for further research.A comprehensive, narrative review of relevant literature was conducted using Medline, MIDIRS, PsycInfo and CINAHL databases. Appropriate search terms were combined with Boolean operators to ensure the following broad areas were included: obstetric decision-making, parental involvement, late preterm and early term birth, and mode of delivery.This review suggests that parents' preferences with respect to their inclusion in decision-making vary. Most mothers prefer sharing decision-making with their clinicians and up to half are dissatisfied with the extent of their involvement. Clinicians' opinions on the limits of parental involvement, especially where the safety of mother or baby is potentially compromised, are highly influential in the obstetric decision-making process. Other important factors include contextual factors (such as the nature of the issue under discussion and the presence or absence of relevant medical indications for a requested intervention), demographic and other individual characteristics (such as ethnicity and parity), the quality of communication; and the information provided to parents.This review highlights the overarching need to explore how decisions about potential LPET delivery may be reached in order to maximise the satisfaction of mothers and fathers with their involvement in the decision-making process whilst simultaneously enabling clinicians both to minimise the number of LPET births and to optimise the wellbeing of women and babies.
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Pais , Nascimento Prematuro , Gravidez , Recém-Nascido , Humanos , Feminino , Mães , Nascimento Prematuro/prevenção & controle , Inglaterra , País de GalesRESUMO
BACKGROUND: The increasing population of immigrant and migrant women in the United Kingdom has implications to the provision of healthcare and for healthcare experiences. Eliciting women's experiences and perceptions of maternity care received is an important way of monitoring and evaluating the quality of maternity services. This study was designed to explore the maternity care experiences of ethnic minority and migrant women in the United Kingdom. METHODS: A literature search for relevant studies was carried across seven databases. We included nine studies carried out between 2015 and February 2022 that met the inclusion criteria. Data were analyzed using a thematic analysis approach. RESULTS: Findings showed that ethnic minority women and migrant women have had mixed experiences while utilizing maternity services in the United Kingdom. However, most of the experiences were negative and included issues related to communication, discrimination, culture, access to care, physical comfort, and continuity of care. Only one of the studies reported that the respondents had a wholly positive communication experience, one found that a few women felt the staff were respectful and one reported that the midwives gave the women treatment options that would respect their cultural and religious beliefs. CONCLUSION: This study has highlighted some important gaps in the maternity care experiences specific to ethnic minority and migrant women in the United Kingdom which provides useful insights to future policy and clinical practice.
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Serviços de Saúde Materna , Migrantes , Feminino , Gravidez , Humanos , Etnicidade , Minorias Étnicas e Raciais , Grupos Minoritários , Reino Unido , Pesquisa QualitativaRESUMO
BACKGROUND: Observational data have shown that slow advancement of enteral feeding volumes in preterm infants is associated with a reduced risk of necrotizing enterocolitis but an increased risk of late-onset sepsis. However, data from randomized trials are limited. METHODS: We randomly assigned very preterm or very-low-birth-weight infants to daily milk increments of 30 ml per kilogram of body weight (faster increment) or 18 ml per kilogram (slower increment) until reaching full feeding volumes. The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months. Secondary outcomes included components of the primary outcome, confirmed or suspected late-onset sepsis, necrotizing enterocolitis, and cerebral palsy. RESULTS: Among 2804 infants who underwent randomization, the primary outcome could be assessed in 1224 (87.4%) assigned to the faster increment and 1246 (88.7%) assigned to the slower increment. Survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 of 1224 infants (65.5%) assigned to the faster increment and 848 of 1246 (68.1%) assigned to the slower increment (adjusted risk ratio, 0.96; 95% confidence interval [CI], 0.92 to 1.01; P = 0.16). Late-onset sepsis occurred in 414 of 1389 infants (29.8%) in the faster-increment group and 434 of 1397 (31.1%) in the slower-increment group (adjusted risk ratio, 0.96; 95% CI, 0.86 to 1.07). Necrotizing enterocolitis occurred in 70 of 1394 infants (5.0%) in the faster-increment group and 78 of 1399 (5.6%) in the slower-increment group (adjusted risk ratio, 0.88; 95% CI, 0.68 to 1.16). CONCLUSIONS: There was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months in very preterm or very-low-birth-weight infants with a strategy of advancing milk feeding volumes in daily increments of 30 ml per kilogram as compared with 18 ml per kilogram. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; SIFT Current Controlled Trials number, ISRCTN76463425.).
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Deficiências do Desenvolvimento/prevenção & controle , Nutrição Enteral/métodos , Fórmulas Infantis , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Leite Humano , Pré-Escolar , Nutrição Enteral/efeitos adversos , Enterocolite Necrosante/prevenção & controle , Seguimentos , Humanos , Recém-Nascido , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Unidades de Terapia Intensiva Neonatal , Tempo de Internação , Sepse/prevenção & controleRESUMO
AIM: Children born very preterm require additional specialist care because of the health and developmental risks associated with preterm birth, but information on their health service use is sparse. We sought to describe the use of specialist services by children born very preterm in Europe. METHOD: We analysed data from the multi-regional, population-based Effective Perinatal Intensive Care in Europe (EPICE) cohort of births before 32 weeks' gestation in 11 European countries. Perinatal data were abstracted from medical records and parents completed a questionnaire at 2 years corrected age (4322 children; 2026 females, 2296 males; median gestational age 29wks, interquartile range [IQR] 27-31wks; median birthweight 1230g, IQR 970-1511g). We compared parent-reported use of specialist services by country, perinatal risk (based on gestational age, small for gestational age, and neonatal morbidities), maternal education, and birthplace. RESULTS: Seventy-six per cent of the children had consulted at least one specialist, ranging across countries from 53.7% to 100%. Ophthalmologists (53.4%) and physiotherapists (48.0%) were most frequently consulted, but individual specialists varied greatly by country. Perinatal risk was associated with specialist use, but the gradient differed across countries. Children with more educated mothers had higher proportions of specialist use in three countries. INTERPRETATION: Large variations in the use of specialist services across Europe were not explained by perinatal risk and raise questions about the strengths and limits of existing models of care. WHAT THIS PAPER ADDS: Use of specialist services by children born very preterm varied across Europe. This variation was observed for types and number of specialists consulted. Perinatal risk was associated with specialist care, but did not explain country-level differences. In some countries, mothers' educational level affected use of specialist services.
UTILIZACIÓN DE SERVICIOS DE SALUD ESPECIALIZADOS EN UN ESTUDIO DE COHORTE EUROPEO DE NIÑOS NACIDOS MUY PREMATUROS: OBJETIVO: Niños nacidos muy prematuramente requieren cuidados especializados adicionales debido a su salud y a los riesgos asociados con la prematuros, sin embargo la información sobre el uso de servicios de salud es escasa. Buscamos describir la utilización de servicios especializados por niños nacidos muy prematuramente, en Europa. MÉTODO: Analizamos datos de una cohorte de nacimientos ocurridos antes de las 32 semanas de gestación tomados del Effective Perinatal Intensive Care in Europe (EPICE), basado en la población y multirregional, en 11 países europeos. Los datos perinatales fueron extraídos de las historias clínicas y los padres completaron un cuestionario a los 2 años de edad corregida (4.322 niños; 2026 sexo femenino, 2.296 masculino; edad gestacional mediana 29 semanas, rango intercuartílico (IQR) 27-31 semanas; mediana de peso de nacimiento 1.230 gr, IQR 970-1.511 gr). Comparamos el uso de servicios especializados (según informe de los padres) por país, riesgo perinatal (basado en edad gestacional, bajo peso para edad gestacional y morbilidades neonatales), educación materna y lugar de nacimiento. RESULTADOS: En total 65% de los niños habían consultado por lo menos a un especialista, con un rango entre países de 53,7% a 100%. Los especialistas más frecuentemente consultados fueron Oftalmólogos (53,4%) y Fisioterapeutas (48%) pero los especialistas consultados por cada individuo variaron mucho según el país. El riesgo perinatal se asoció al uso de especialista, pero el gradiente varió entre los países. Niños de madres con mayor nivel educativo tuvieron mayor proporción de uso de especialistas en tres países. INTERPRETACIÓN: Las grandes variaciones en el uso de servicios especializados en Europa no fueron explicadas por el riesgo perinatal y arrojan cuestionamientos sobre las fortalezas y limitaciones de los modelos de cuidados existentes.
USO DE SERVIÇOS DE SAÚDE ESPECIALIZADOS EM UMA COORTE EUROPÉIA DE LACTENTES NASCIDOS MUITO PREMATUROS: OBJETIVO: Crianças nascidas muito prematuras requerem cuidado especializado adicional por causa dos riscos à saúde e ao desenvolvimento associados ao nascimento premature, mas informações sobreo uso de serviços de saúde são escassas. Procuramos descrever o uso de serviços especializados por crianças nascidas muito prematuras na Europa. MÉTODO: Analisamos dados de uma coorte populacional multi-regional, do Cuidado Intensivo Neonatal Efetivo na Europa (EPICE), com lactentes nascidos antes de 32 semanas de gestação em 11 países europeus. Dados perinatais foram extraídos dos registros médicos, e os pais completaram um questionário com 2 anos de idade corrigida (4.322 crianças; 2.026 do sexo feminino, 2.296 do sexo masculino; idade gestacional mediana 29semanas, intervalo interquartile [IIQ] 27-31sem; peso ao nascimento mediano 1,230g, IIQ 970-1511g). Comparamos o uso de serviços especializados reportados pelos pais por país, risco perinatal (com base na idade gestacional, pequeno para a idade gestacional e morbidades neonatais), educação materna e local de nascimento. RESULTADOS: Setenta e seis por cento das crianças consultou pelo menos um especialista, variando entre países de 53,7 a 100%. Oftalmologistas (53,4%) e fisioterapeutas (48,0%) foram os mais frequentemente consultados, mas os especialistas individuais variaram bastante por país. O risco perinatal se associou com uso de serviços especializados, mas o gradient diferiu entre países. Crianças com mães mais educadas tinham maior proporção de uso de especialistas em três países. INTERPRETAÇÃO: Grandes variações no uso de serviços especializados na Europa não foram explicadas pelo risco perinatal, e levantam questões sobre as forças e limitações dos modelos de cuidado existentes.
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Lactente Extremamente Prematuro , Aceitação pelo Paciente de Cuidados de Saúde , Especialização , Pré-Escolar , Estudos de Coortes , Europa (Continente)/epidemiologia , Feminino , Geografia Médica , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Masculino , Fatores de Risco , Fatores SocioeconômicosRESUMO
BACKGROUND: The 'Surviving Crying' study was designed to develop and provisionally evaluate a support service for parents of excessively crying babies, including its suitability for use in the United Kingdom (UK) National Health Service (NHS). The resulting service includes three materials: a website, a printed booklet, and a Cognitive Behaviour Therapy (CBT) programme delivered to parents by a qualified professional. This study aimed to measure whether parents used the materials and to obtain parents' and NHS professionals' evaluations of whether they are fit for purpose. Parents were asked about participating in a randomised controlled trial (RCT) to evaluate the materials fully in health service use. METHODS: Participants were 57 parents with babies they judged to be crying excessively and 96 NHS Health Visitors (HVs). Parental use and parents' and HVs' ratings of the Surviving Crying materials were measured. RESULTS: Thirty four parents reported using the website, 24 the printed booklet and 24 the CBT sessions. Parents mostly accessed the website on mobile phones or tablets and use was substantial. All the parents and almost all HVs who provided data judged the materials to be helpful for parents and suitable for NHS use. If offered a waiting list control group, 85% of parents said they would have been willing to take part in a full RCT evaluation of the Surviving Crying package. DISCUSSION AND CONCLUSIONS: The findings identify the need for materials to support parents of excessively crying babies within national health services in the UK. The Surviving Crying support package appears suitable for this purpose and a full community-level RCT of the package is feasible and likely to be worthwhile. Limitations to the study and barriers to delivery of the services were identified, indicating improvements needed in future research. TRIAL REGISTRATION: Study Registration no. ISRCTN84975637 .
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Terapia Cognitivo-Comportamental/métodos , Choro/psicologia , Pais/psicologia , Apoio Social , Adulto , Atitude do Pessoal de Saúde , Estudos de Viabilidade , Feminino , Humanos , Lactente , Internet , Masculino , Folhetos , Poder Familiar/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Satisfação do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Telemedicina/métodos , Reino UnidoRESUMO
Until recently, there has been a strongly held belief on the part of neonatal and pediatric clinicians that outcomes for infants born close to term are not different from those of babies born at full term. In the last decade, however, this assumption has been challenged by reports suggesting that this is not correct, and highlighting differences in morbidity and mortality both in the short and long term. This has led to development of new terminology to more accurately reflect the impact of immaturity associated with birth at 32-33 weeks (moderately preterm) and 34-36 weeks (late preterm) of gestation. These babies account for around 5-7% of all births and more than 75% of the preterm births in developed countries, so this new recognition of the associated increase in adverse outcomes may have a substantial impact on health care services. This review article will discuss the changing perceptions and concepts of gestational age in the preterm population, and explore the recent and emerging evidence around neonatal, early childhood, school-age, adolescent and adult outcomes for babies who are born moderately preterm and late preterm. It highlights important neonatal and childhood morbidities and will summarize associated health care, developmental and educational problems of affected children. The implications for the provision of ongoing primary and secondary health care, educational and social support to this large and heterogeneous group of individuals will be discussed.
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Atenção à Saúde/métodos , Doenças do Prematuro/epidemiologia , Recém-Nascido Prematuro , Criança , Deficiências do Desenvolvimento/epidemiologia , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Gravidez , Apoio SocialRESUMO
OBJECTIVES: To explore patterns of comorbidity in cognitive and behavioral outcomes at 2 years' corrected age among children born late or moderately preterm (LMPT) and to identify predictors of different patterns of comorbidity. STUDY DESIGN: Geographical, prospective population-based cohort study of 1139 infants born LMPT (320/7 to 366/7 weeks' gestation) and 1255 infants born at term (370/7 to 426/7 weeks' gestation). Parent questionnaires were obtained to identify impaired cognitive and language development, behavioral problems, delayed social-emotional competence, autistic features, and clinically significant eating difficulties at 24 months corrected age for 638 (57%) children born LMPT and 765 (62%) children born at term. RESULTS: Latent class analysis revealed 2 profiles of development among the term group: optimal (84%) and a profile of social, emotional, and behavioral impairments termed "nonoptimal" (16%). These 2 profiles were also identified among the LMPT group (optimal: 67%; nonoptimal: 26%). In the LMPT group, a third profile was identified (7%) that was similar to the phenotype previously identified in infants born very preterm. Nonwhite ethnicity, socioeconomic risk, and not receiving breast milk at hospital discharge were risk factors for nonoptimal outcomes in both groups. Male sex, greater gestational age, and pre-eclampsia were only associated with the preterm phenotype. CONCLUSIONS: Among children born LMPT with parent-reported cognitive or behavioral impairments, most had problems similar to the profile of difficulties observed in children born at term. A smaller proportion of children born LMPT had impairments consistent with the "very preterm phenotype" which are likely to have arisen through a preterm pathway. These results suggest that prematurity may affect development through several etiologic pathways in the late and moderately preterm population.
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Desenvolvimento Infantil , Recém-Nascido Prematuro/crescimento & desenvolvimento , Transtornos do Neurodesenvolvimento/epidemiologia , Nascimento Prematuro , Pré-Escolar , Estudos de Coortes , Comorbidade , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Masculino , Transtornos do Neurodesenvolvimento/etiologia , Fenótipo , Estudos Prospectivos , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
AIM: Evaluation of comfort and pain in neonates is important for management. Specific signs of persistent pain in neonates remain undefined; few validated clinical tools assess persistent pain. We sought to determine (i) difficulty perceived by staff and parents in assessing comfort/persistent pain in babies, (ii) strategies employed when no clinical tool is used and (iii) variation between clinicians' assessments. METHODS: Parent and staff questionnaires addressed difficulty in assessing pain/comfort in neonates and strategies used in making assessments. RESULTS: A total of 47 of 50 (94%) parents and 83 of 91 (91%) staff participated; 50% of staff reported it was moderately/very difficult to assess persistent pain, and 13% very easy; 75% of parents found it moderately/very easy and 23% difficult to assess their baby's comfort; 15% of parents thought staff found pain assessment difficult. Staff described 94 different factors indicative of comfort and 139 factors of persistent pain. Terminology differed widely and was often nonspecific; 67% of staff described forming a 'general impression'. CONCLUSION: Pain assessment is challenging for staff. Most parents feel confident in assessing their babies' comfort, but may overestimate the ease with which staff can do so. Indicators of persistent pain/comfort are poorly defined; staff use differing, subjective assessments, which may complicate communication between carers.
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Terapia Intensiva Neonatal/métodos , Terapia Intensiva Neonatal/psicologia , Medição da Dor/métodos , Medição da Dor/psicologia , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Terapia Intensiva Neonatal/estatística & dados numéricos , Medição da Dor/estatística & dados numéricos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Relatively little is known about the effects of mode of delivery on long-term health-related quality-of-life outcomes. Furthermore, no previous study has expressed these outcomes in preference-based (utility) metrics. METHODS: The study population comprised 2,161 mothers recruited from a prospective population-based study in the East Midlands of England encompassing live births and stillbirths between 32+0 and 36+6 weeks' gestation and a sample of term-born controls. Perinatal data were extracted from the mothers' maternity records. Health-related quality-of-life outcomes were assessed at 12 months postpartum, using the EuroQol Five Dimensions (EQ-5D) measure with responses to the EQ-5D descriptive system converted into health utility scores. Descriptive statistics and multivariable analyses were used to estimate the relationship between the mode of delivery and health-related quality-of-life outcomes. RESULTS: The overall health-related quality-of-life profile of the women in the study cohort mirrored that of the English adult population as revealed by national health surveys. A significantly higher proportion of women delivering by cesarean delivery reported some, moderate, severe, or extreme pain or discomfort at 12 months postpartum than women undergoing spontaneous vaginal delivery. Multivariable analyses, using the Ordinary Least Squares estimator revealed that, after controlling for maternal sociodemographic characteristics, cesarean delivery without maternal or fetal compromise was associated with a significant EQ-5D utility decrement in comparison to spontaneous vaginal delivery among all women (-0.026; p = 0.038) and among mothers of term-born infants (-0.062; p < 0.001). Among mothers of term-born infants, this result was replicated in models that controlled for all maternal and infant characteristics (utility decrement of -0.061; p < 0.001). The results were confirmed by sensitivity analyses that varied the categorization of the main exposure variable (mode of delivery) and the econometric strategy. CONCLUSIONS: Among mothers of term-born infants, cesarean delivery without maternal or fetal compromise is associated with poorer long-term health-related quality of life in comparison to spontaneous vaginal delivery. Further longitudinal studies are needed to understand the magnitude, trajectory, and underpinning mechanisms of health-related quality-of-life outcomes following different modes of delivery.
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Cesárea/estatística & dados numéricos , Resultado da Gravidez , Qualidade de Vida , Adulto , Inglaterra/epidemiologia , Feminino , Idade Gestacional , Inquéritos Epidemiológicos , Humanos , Recém-Nascido , Modelos Logísticos , Masculino , Análise Multivariada , Parto , Período Pós-Parto , Gravidez , Estudos Prospectivos , Adulto JovemRESUMO
BACKGROUND: In the UK, 1-2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth. METHODS/DESIGN: Two thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire. DISCUSSION: Extensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal feeding strategy, and therefore if successful, the trial results could rapidly be adopted across the NHS at low cost. TRIAL REGISTRATION: ISRCTN Registry; ISRCTN76463425 on 5 March, 2013.
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Deficiências do Desenvolvimento/prevenção & controle , Nutrição Enteral/métodos , Doenças do Prematuro/prevenção & controle , Terapia Intensiva Neonatal/métodos , Leite Humano , Nutrição Parenteral/métodos , Pré-Escolar , Protocolos Clínicos , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Masculino , Estudos Prospectivos , Fatores de TempoRESUMO
AIM: Continuous pain occurs routinely, even after invasive procedures, or inflammation and surgery, but clinical practices associated with assessments of continuous pain remain unknown. METHODS: A prospective cohort study in 243 neonatal intensive care units (NICUs) from 18 European countries recorded the frequency of pain assessments, use of mechanical ventilation, sedation, analgesia or neuromuscular blockade for each neonate for up to 28 days after NICU admission. RESULTS: Only 2113 of 6648 (31.8%) of neonates received assessments of continuous pain, occurring variably among tracheal ventilation (TrV, 46.0%), noninvasive ventilation (NiV, 35.0%) and no ventilation (NoV, 20.1%) groups (p < 0.001). Daily assessments for continuous pain occurred in only 10.4% of all neonates (TrV: 14.0%, NiV: 10.7%, NoV: 7.6%; p < 0.001). More frequent assessments of continuous pain occurred in NICUs with pain guidelines, nursing champions and surgical admissions (all p < 0.01), and for newborns <32 weeks gestational age, those requiring ventilation, or opioids, sedatives-hypnotics, general anaesthetics (O-SH-GA) (all p < 0.001), or surgery (p = 0.028). Use of O-SH-GA drugs increased the odds for pain assessment in the TrV (OR:1.60, p < 0.001) and NiV groups (OR:1.40, p < 0.001). CONCLUSION: Assessments of continuous pain occurred in less than one-third of NICU admissions and daily in only 10% of neonates. NICU clinical practices should consider including routine assessments of continuous pain in newborns.
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Dor Crônica/diagnóstico , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Medição da Dor/estatística & dados numéricos , Europa (Continente) , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Estudos Prospectivos , Respiração ArtificialRESUMO
OBJECTIVES: To assess the prevalence of positive screens using the Modified Checklist for Autism in Toddlers (M-CHAT) questionnaire and follow-up interview in late and moderately preterm (LMPT; 32-36 weeks) infants and term-born controls. STUDY DESIGN: Population-based prospective cohort study of 1130 LMPT and 1255 term-born infants. Parents completed the M-CHAT questionnaire at 2-years corrected age. Parents of infants with positive questionnaire screens were followed up with a telephone interview to clarify failed items. The M-CHAT questionnaire was re-scored, and infants were classified as true or false positives. Neurosensory, cognitive, and behavioral outcomes were assessed using parent report. RESULTS: Parents of 634 (57%) LMPT and 761 (62%) term-born infants completed the M-CHAT questionnaire. LMPT infants had significantly higher risk of a positive questionnaire screen compared with controls (14.5% vs 9.2%; relative risk [RR] 1.58; 95% CI 1.18, 2.11). After follow-up, significantly more LMPT infants than controls had a true positive screen (2.4% vs 0.5%; RR 4.52; 1.51, 13.56). This remained significant after excluding infants with neurosensory impairments (2.0% vs 0.5%; RR 3.67; 1.19, 11.3). CONCLUSIONS: LMPT infants are at significantly increased risk for positive autistic screen. An M-CHAT follow-up interview is essential as screening for autism spectrum disorders is especially confounded in preterm populations. Infants with false positive screens are at risk for cognitive and behavioral problems.
Assuntos
Transtorno Autístico/diagnóstico , Doenças do Prematuro/diagnóstico , Lista de Checagem , Pré-Escolar , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Estudos Prospectivos , Medição de Risco , Inquéritos e QuestionáriosRESUMO
The design and synthesis of tripodal ligands 1-3 based upon the N-methyl-1,3,5-benzenetricarboxamide platform appended with three aryl urea arms is reported. This ligand platform gives rise to highly preorganized structures and is ideally suited for binding SO4 (2-) and H2 PO4 (-) ions through multiple hydrogen-bonding interactions. The solid-state crystal structures of 1-3 with SO4 (2-) show the encapsulation of a single anion within a cage structure, whereas the crystal structure of 1 with H2 PO4 (-) showed that two anions are encapsulated. We further demonstrate that ligand 4, based on the same platform but consisting of two bis-urea moieties and a single ammonium moiety, also recognizes SO4 (2-) to form a self-assembled capsule with [4:4] SO4 (2-) :4 stoichiometry in which the anions are clustered within a cavity formed by the four ligands. This is the first example of a self-sorting self-assembled capsule where four tetrahedrally arranged SO4 (2-) ions are embedded within a hydrophobic cavity.
Assuntos
Benzamidas/química , Fosfatos/química , Sulfatos/química , Ureia/análogos & derivados , Sítios de Ligação , Ligação de Hidrogênio , Ligantes , Metilação , Modelos MolecularesRESUMO
Thiourea-functionalized Tröger's base receptors 1 and 2 have been synthesized and evaluated as novel for the recognition of anions. Receptor 2 gave rise to significant changes in the absorption spectrum upon titration with AcO(-) and H2PO4(-) and acted as a colorimetric sensor for F(-), the interaction of which was also evaluated using (1)H NMR spectroscopy.