272 results found
Modi N, 2020, Votes for a better future, ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 105, Pages: 13-14, ISSN: 0003-9888
Webbe J, Ali S, Sakonidou S, et al., 2019, Inconsistent outcome reporting in large neonatal trials: a systematic review, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 105, Pages: 69-75, ISSN: 1359-2998
ObjectiveInconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.DesignA literature search of CENTRAL, CINAHL, EMBASE and Medline was conducted; randomised trials published between July 1st 2012 and July 1st 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted.ResultsSeventy six trials involving 43126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection.ConclusionsInconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.
Jawad S, Modi N, Prevost AT, et al., 2019, A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data, Trials, Vol: 20, ISSN: 1745-6215
BackgroundWe aimed to test whether a common set of key data items reported across high impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD). MethodsWe systematically reviewed neonatal clinical trials published in four high impact medical journals over 10 years (2006-2015) and extracted baseline characteristics, stratification items, and potential confounders used to adjust primary outcomes. Completeness was examined using data held in the NNRD for identified data items, for infants admitted to neonatal units in 2015. The NNRD is a repository of routinely recorded data extracted from neonatal Electronic Patient Records (EPR) of all admissions to National Health Service (NHS) Neonatal Units in England, Wales and Scotland. We defined missing data as an empty field or an implausible value. We reported common data items as frequencies and percentages alongside percentages of completeness. ResultsWe identified 44 studies involving 32,095 infants and 126 data items. Fourteen data items were reported by more than 20% of studies (table 2). Gestational age (95%), sex (93%) and birth weight (91%) were the most common baseline data items. The completeness of data in the NNRD was high for these data with greater than 90% completeness found for 9 of the 14 most common items.Conclusion High impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined.
Parkinson JRC, Emsley R, Adkins JLT, et al., 2019, Clinical and molecular evidence of accelerated ageing following very preterm birth, Pediatric Research, ISSN: 0031-3998
BACKGROUND: The mechanisms responsible for the associations between very preterm birth and a higher risk of poor cardiovascular and metabolic health in adult life are unknown. METHODS: Here, we compare the clinical and molecular phenotypes of healthy, normal-weight young adults (18-27 years), born very preterm (<33 weeks gestational age (GA)) and at full-term (37-42 weeks GA). Outcomes included whole-body MRI, hepatic and muscle 1H MRS, blood pressure measurements and telomere length. RESULTS: We recruited 156 volunteers, 69 preterm (45 women; 24 men) and 87 born at full-term (45 women; 42 men). Preterm individuals had a significantly altered blood pressure profile, including higher systolic blood pressure (SBP mmHg: preterm men 133.4 ± 10.1, term men 23.0 ± 6.9; preterm women 124.3 ± 7.1, term women 118.4 ± 8.0, p < 0.01 for all). Furthermore, preterm men had fewer long telomeres (145-48.5 kb: preterm men 14.1 ± 0.9%, term men 17.8 ± 1.1%, p < 0.05; 48.5-8.6 kb: preterm men 28.2 ± 2.6, term men 37.0 ± 2.4%, p < 0.001) and a higher proportion of shorter telomeres (4.2-1.3 kb: preterm men 40.4 ± 3.5%, term men 29.9 ± 3.2%, p < 0.01). CONCLUSION: Our data indicate that healthy young adults born very preterm manifest clinical and molecular evidence of accelerated ageing.
Lui K, Lee SK, Kusuda S, et al., 2019, Trends in Outcomes for Neonates Born Very Preterm and Very Low Birth Weight in 11 High-Income Countries, JOURNAL OF PEDIATRICS, Vol: 215, Pages: 32-+, ISSN: 0022-3476
Webbe J, Duffy JMN, Afonso E, et al., Core outcomes in neonatology: Development of a core outcome set for neonatal research, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998
BackgroundNeonatal research evaluates many different outcomes using multiple measures. This canprevent synthesis of trial results in meta-analyses and selected outcomes may not berelevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care ina high income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed.Stakeholders were recruited for a three-round international Delphi survey. A consensusmeeting was held to confirm the final COS, based upon the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals andresearchers took part in the eDelphi survey; 173 completed all 3 rounds. Sixteenstakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round one.Participants proposed ten additional outcomes; 114 outcomes were scored in round two andthree. Round one scores showed different stakeholder groups prioritised contrastingoutcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotisingenterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability,quality of life, adverse events, visual impairment/blindness, hearing impairment /deafness,retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.6Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal carein a high-income setting has been identified. This COS for neonatology will help standardiseoutcome selection in clinical trials and ensure these are relevant to those most affected byneonatal care.
Shahroor M, Lehtonen L, Lee SK, et al., 2019, Unit-Level Variations in Healthcare Professionals' Availability for Preterm Neonates < 29 Weeks' Gestation: An International Survey, NEONATOLOGY, Vol: 116, Pages: 347-355, ISSN: 1661-7800
Helenius K, Longford N, Lehtonen L, et al., 2019, Association of early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury in extremely preterm infants: observational cohort study with propensity score matching, BMJ: British Medical Journal, Vol: 367, Pages: 1-11, ISSN: 0959-535X
Objective To determine if postnatal transfer or birth in a non-tertiary hospital is associated with adverse outcomes.Design Observational cohort study with propensity score matching.Setting National health service neonatal care in England; population data held in the National Neonatal Research Database.Participants Extremely preterm infants born at less than 28 gestational weeks between 2008 and 2015 (n=17 577) grouped based on birth hospital and transfer within 48 hours of birth: upward transfer (non-tertiary to tertiary hospital, n=2158), non-tertiary care (born in non-tertiary hospital; not transferred, n=2668), and controls (born in tertiary hospital; not transferred, n=10 866). Infants were matched on propensity scores and predefined background variables to form subgroups with near identical distributions of confounders. Infants transferred between tertiary hospitals (horizontal transfer) were separately matched to controls in a 1:5 ratio.Main outcome measures Death, severe brain injury, and survival without severe brain injury.Results 2181 infants, 727 from each group (upward transfer, non-tertiary care, and control) were well matched. Compared with controls, infants in the upward transfer group had no significant difference in the odds of death before discharge (odds ratio 1.22, 95% confidence interval 0.92 to 1.61) but significantly higher odds of severe brain injury (2.32, 1.78 to 3.06; number needed to treat (NNT) 8) and significantly lower odds of survival without severe brain injury (0.60, 0.47 to 0.76; NNT 9). Compared with controls, infants in the non-tertiary care group had significantly higher odds of death (1.34, 1.02 to 1.77; NNT 20) but no significant difference in the odds of severe brain injury (0.95, 0.70 to 1.30) or survival without severe brain injury (0.82, 0.64 to 1.05). Compared with infants in the upward transfer group, infants in the non-tertiary care group had no significant difference in death before discharge (1.10, 0.84
Gale C, Modi N, Jawad S, et al., 2019, The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial., BMJ Open, Vol: 9, Pages: 1-7, ISSN: 2044-6055
INTRODUCTION: Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment. METHODS AND ANALYSIS: We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at <30+0 gestational weeks+days. Primary feasibility outcomes will be rate of recruitment, opt-out, retention, compliance, data completeness and data accuracy; clinical outcomes will include mortality and NEC. The trial will recruit in two neonatal networks in England for 9 months. Data collection will continue until all infants have reached 40+0 corrected gestational weeks or neonatal discharge. Participant identification and recruitment, randomisation and all trial data collection will be embedded within existing neonatal EPR systems (BadgerNet and BadgerEPR); outcome data will be extracted from routinely recorded data held in the National Neonatal Research Database. ETHICS AND DISSEMINATION: This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will infor
Gale C, Modi N, Jawad S, et al., Study Protocol: The WHEAT pilot trial - WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multi-centre, electronic patient record (EPR), randomised controlled point-of-care pilot trial, BMJ Open, ISSN: 2044-6055
Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red-cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red-cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment.
Mills L, Coulter L, Savage E, et al., 2019, Macronutrient content of donor milk from a regional human milk bank: variation with donor mother-infant characteristics., The British Journal of Nutrition: an international journal of nutritional science, Vol: 122, Pages: 1155-1167, ISSN: 0007-1145
Better understanding of the variation in macronutrient content of human donor milk (HDM) potentiates targeted nutrition for preterm babies. This study describes the relationship of maternal age, parity, monthly lactation stage estimate (LSEm), daily volume of milk expressed (Vd), sex, gestation, and birthweight z scores, with macronutrient content of HDM. Multilevel mother-infant pair ID random intercept models were performed using the predictor variables above on the outcome HDM macronutrient content determined using mid infrared spectroscopy. Mean macronutrient content was also compared by gestational age, and small or appropriate for gestational age (SGA) (z score <-1.28) or (AGA) (z score ≥ -1.28) categories. 2966 samples of donations from 1175 mother-infant pairs to the UK North West Human Milk Bank between 2011-2017 were analysed. Mean (sd) protein, fat, carbohydrate, and calculated energy, were 0.89 (0.24) g/dl, 2.99 (0.96) g/dl, 7.09 (0.44) g/dl, and 60.37 (8.41) kcal/dl respectively. Preterm SGA HDM was significantly higher in protein, fat, and energy content than term AGA HDM, and significantly lower in carbohydrate content than term AGA HDM after controlling for LSEm, Vd, and between subject effects. Degree of prematurity did not influence macronutrient content. Between subject effects accounted for more of the variance in macronutrient content than the fixed effects in the model. Despite this, SGA status, as well as prematurity, may be an important determinant of macronutrient content in human milk. As bioavailability of macronutrients from HDM is uncertain, studies evaluating growth and body composition in preterm and SGA babies fed HDM are warranted.
Modi N, Ashby D, Battersby C, et al., 2019, Developing routinely recorded clinical data from electronic patient records as a national resource to improve neonatal health care: the Medicines for Neonates research programme, Programme Grants for Applied Research, Vol: 7, Pages: 1-396, ISSN: 2050-4322
BackgroundClinical data offer the potential to advance patient care. Neonatal specialised care is a high-cost NHS service received by approximately 80,000 newborn infants each year.Objectives(1) To develop the use of routinely recorded operational clinical data from electronic patient records (EPRs), secure national coverage, evaluate and improve the quality of clinical data, and develop their use as a national resource to improve neonatal health care and outcomes. To test the hypotheses that (2) clinical and research data are of comparable quality, (3) routine NHS clinical assessment at the age of 2 years reliably identifies children with neurodevelopmental impairment and (4) trial-based economic evaluations of neonatal interventions can be reliably conducted using clinical data. (5) To test methods to link NHS data sets and (6) to evaluate parent views of personal data in research.DesignSix inter-related workstreams; quarterly extractions of predefined data from neonatal EPRs; and approvals from the National Research Ethics Service, Health Research Authority Confidentiality Advisory Group, Caldicott Guardians and lead neonatal clinicians of participating NHS trusts.SettingNHS neonatal units.ParticipantsNeonatal clinical teams; parents of babies admitted to NHS neonatal units.InterventionsIn workstream 3, we employed the Bayley-III scales to evaluate neurodevelopmental status and the Quantitative Checklist of Autism in Toddlers (Q-CHAT) to evaluate social communication skills. In workstream 6, we recruited parents with previous experience of a child in neonatal care to assist in the design of a questionnaire directed at the parents of infants admitted to neonatal units.Data sourcesData were extracted from the EPR of admissions to NHS neonatal units.Main outcome measuresWe created a National Neonatal Research Database (NNRD) containing a defined extract from real-time, point-of-care, clinician-entered EPRs from all NHS neonatal units in England, Wales and Scotland (
Seaton SE, Draper ES, Abrams KR, et al., 2019, Can we estimate the length of stay of very preterm multiples?, ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, Vol: 104, Pages: F568-+, ISSN: 1359-2998
Caplan MS, Underwood MA, Modi N, et al., 2019, Necrotizing enterocolitis: using regulatory science and drug development to improve outcomes, Journal of Pediatric Ophthalmology and Strabismus, Vol: 212, Pages: 208-215.e1, ISSN: 0022-345X
Helenius K, Longford N, Lehtonen L, et al., Association between early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury: a whole-population study of extremely preterm infants, BMJ, ISSN: 0959-8138
Pillay T, Modi N, Rivero-Arias O, et al., 2019, Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol., BMJ Open, Vol: 9, Pages: 1-9, ISSN: 2044-6055
INTRODUCTION: In England, for babies born at 23-26 weeks gestation, care in a neonatal intensive care unit (NICU) as opposed to a local neonatal unit (LNU) improves survival to discharge. This evidence is shaping neonatal health services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born at 27-31 weeks gestation) whose care is currently spread between 45 NICU and 84 LNU in England. This group represents 12% of preterm births in England and over onr-third of all neonatal unit care days. Compared with those born at 23-26 weeks gestation, they account for four times more admissions and twice as many National Health Service bed days/year. METHODS: In this mixed-methods study, our primary objective is to assess, for babies born at 27-31 weeks gestation and admitted to a neonatal unit in England, whether care in an NICU vs an LNU impacts on survival and key morbidities (up to age 1 year), at each gestational age in weeks. Routinely recorded data extracted from real-time, point-of-care patient management systems held in the National Neonatal Research Database, Hospital Episode Statistics and Office for National Statistics, for January 2014 to December 2018, will be analysed. Secondary objectives are to assess (1) whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, (2) where care is most cost-effective and (3) what parents' and clinicians' perspectives are on place of care, and how these could guide clinical decision-making. Our findings will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy-making. The project is supported by a parent advisory panel and a study steering committee. ETHICS AND DISSEMINATION: Research ethics approval has been obtained (IRAS 212304). Dissemination will be through publication of findings and development of recommendations for care. TRIAL REGISTRATION
Modi N, 2019, Information technology infrastructure, quality improvement and research: the UK National Neonatal Research Database, Translational pediatrics, Vol: 8, Pages: 193-198, ISSN: 2224-4344
Technological developments, coupled with strengthened governance and data security have led to increasing recognition of the potential of real-world health data to benefit patient care and health services. Real-world health data are those captured in the course of routine care. Here I describe a mature source of real-world health data, the UK National Neonatal Research Database and provide examples of the many types of uses it supports.
Webbe J, Longford N, Uthaya S, et al., 2019, Outcomes following early parenteral nutrition use in preterm neonates: Protocol for an observational study, BMJ Open, Vol: 9, Pages: 1-5, ISSN: 2044-6055
Introduction Preterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland. We will also evaluate if this is associated with differences in important neonatal outcomes in neonates born between 30+0 and 32+6 weeks+days gestation.Methods and analysis We will use routinely collected data from all neonatal units in England, Wales and Scotland, available in the National Neonatal Research Database (NNRD). We will describe clinical practice in relation to any use of PN during the first 7 postnatal days among neonates admitted to neonatal care between 1 January 2012 and 31 December 2017. We will compare outcomes in neonates born between 30+0 and 32+6 weeks+days gestation who did or did not receive PN in the first week after birth using a propensity score-matched approach. The primary outcome will be survival to discharge home. Secondary outcomes will include components of the neonatal core outcome set: outcomes identified as important by former patients, parents, clinicians and researchers.Ethics and dissemination We have obtained UK National Research Ethics Committee approval for this study (Ref: 18/NI/0214). The results of this study will be presented at academic conferences; the UK charity Bliss will aid dissemination to former patients and parents.
Shah PS, Lui K, Reichman B, et al., 2019, The International Network for Evaluating Outcomes (iNeo) of neonates: evolution, progress and opportunities, Translational pediatrics, Vol: 8, Pages: 170-+, ISSN: 2224-4344
Neonates born very preterm (before 32 weeks’ gestational age), are a significant public health concern because of their high-risk of mortality and life-long disability. In addition, caring for very preterm neonates can be expensive, both during their initial hospitalization and their long-term cost of permanent impairments. To address these issues, national and regional neonatal networks around the world collect and analyse data from their constituents to identify trends in outcomes, and conduct benchmarking, audit and research. Improving neonatal outcomes and reducing health care costs is a global problem that can be addressed using collaborative approaches to assess practice variation between countries, conduct research and implement evidence-based practices. The International Network for Evaluating Outcomes (iNeo) of neonates was established in 2013 with the goal of improving outcomes for very preterm neonates through international collaboration and comparisons. To date, 10 national or regional population-based neonatal networks/datasets participate in iNeo collaboration. The initiative now includes data on >200,000 very preterm neonates and has conducted important epidemiological studies evaluating outcomes, variations and trends. The collaboration has also surveyed >320 neonatal units worldwide to learn about variations in practices, healthcare service delivery, and physical, environmental and manpower related factors and support services for parents. The iNeo collaboration serves as a strong international platform for Neonatal-Perinatal health services research that facilitates international data sharing, capacity building, and global efforts to improve very preterm neonate care.
Sakonidou S, Andrzejewska I, Kotzamanis S, et al., 2019, Better use of data to improve parent satisfaction (BUDS): protocol for a prospective before-and-after pilot study employing mixed methods to improve parent experience of neonatal care, BMJ Paediatrics Open, Vol: 3, ISSN: 2399-9772
Introduction Having a baby that requires neonatal care is stressful and traumatic. Parents often report dissatisfaction with communication of clinical information. In the UK neonatal care data are recorded daily using electronic patient record systems (EPR), from which deidentified data form the National Neonatal Research Database (NNRD). We aim to evaluate the impact of sharing neonatal EPR data with parents, on parent-reported satisfaction, parent–staff interactions, staff workload and data completeness.Methods A prospective, before-and-after, mixed-method study. Participants are parents of inpatient babies (maximum 90) and staff in a tertiary neonatal intensive care unit, London, UK. The intervention was developed by former neonatal parents, neonatologists and neonatal nurses: a communication tool for parents comprising individualised, written, daily infant updates for parents, derived from EPR data. The intervention will be provided to parents over 6 weeks. Plan-Do-Study-Act cycles will inform the tool’s iterative development and improvement. The tool’s impact will be measured using a validated parent survey, staff survey, data completeness measures and interviews.Analysis Primary outcome: parent satisfaction ‘with communication of clinical information and involvement in care’. Secondary outcomes: parent–staff interactions, staff workload, data completeness. Baseline survey data will be obtained from clinical service evaluation preceding the intervention. Baseline data completeness will be derived from the NNRD. During the intervention, surveys will be administered biweekly and data completeness assessed daily. We will analyse outcomes using run charts and partially paired statistical tests. Parent and staff interviews will explore information exchange and the communication tool’s impact.Discussion This study will evaluate the impact of a parent co-designed intervention on communication with parents in neonatal care and
Li Y, Liu X, Modi N, et al., 2019, Impact of breast milk intake on body composition at term in very preterm babies: secondary analysis of the Nutritional Evaluation and Optimisation in Neonates randomised controlled trial, ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, Vol: 104, Pages: F306-F312, ISSN: 1359-2998
Jenkins HJ, Hyde MJ, Modi N, et al., 2019, An Investigation of 16S rRNA Gene Analysis Platforms for Processing Samples Acquired from Preterm Neonates., 66th Annual Scientific Meeting of the Society-for-Reproductive-Investigation (SRI), Publisher: SAGE PUBLICATIONS INC, Pages: 121A-121A, ISSN: 1933-7191
Battersby C, Modi N, 2019, Challenges in Advancing Necrotizing Enterocolitis Research., Clin Perinatol, Vol: 46, Pages: 19-27
Progressing necrotizing enterocolitis research is difficult because the disease is variable in presentation, there are difficulties in making a precise diagnosis, a reliable agreed case-definition is currently lacking, and there is a paucity of preclinical research to identify etiologic targets. The major challenges of the cost of clinical trials and need for long-term outcome ascertainment could be eased through incorporation of novel randomization approaches and data collection into routine care, and collaboration between public-sector and industry funders.
Seaton SE, Barker L, Draper ES, et al., 2019, Estimating neonatal length of stay for babies born very preterm, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 104, Pages: F182-F186, ISSN: 1359-2998
OBJECTIVE: To predict length of stay in neonatal care for all admissions of very preterm singleton babies. SETTING: All neonatal units in England. PATIENTS: Singleton babies born at 24-31 weeks gestational age from 2011 to 2014. Data were extracted from the National Neonatal Research Database. METHODS: Competing risks methods were used to investigate the competing outcomes of death in neonatal care or discharge from the neonatal unit. The occurrence of one event prevents the other from occurring. This approach can be used to estimate the percentage of babies alive, or who have been discharged, over time. RESULTS: A total of 20 571 very preterm babies were included. In the competing risks model, gestational age was adjusted for as a time-varying covariate, allowing the difference between weeks of gestational age to vary over time. The predicted percentage of death or discharge from the neonatal unit were estimated and presented graphically by week of gestational age. From these percentages, estimates of length of stay are provided as the number of days following birth and corrected gestational age at discharge. CONCLUSIONS: These results can be used in the counselling of parents about length of stay and the risk of mortality.
Molloy E, Mader S, Modi N, et al., 2019, Parent, Child and Public Involvement in Child Health Research: Core value not just an optional extra, Pediatric Research, Vol: 85, Pages: 2-3, ISSN: 0031-3998
Modi N, Ashby D, Battersby C, et al., Using routinely recorded clinical data for research: the Medicines for Neonates research programme, Programme Grants for Applied Research, ISSN: 2050-4322
Background: Clinical data offer potential to advance patient care. Neonatal specialised care is a high cost NHS service received by approximately 80,000 newborn infants each year. Objectives: To 1) develop the use of routinely recorded operational clinical data from Electronic Patient Records (EPR), secure national coverage, evaluate and improve the quality of clinical data, and develop their use as a national resource to improve neonatal healthcare and outcomes; test the hypotheses that 2) clinical and research data are of comparable quality; 3) routine NHS clinical assessment at age two-years reliably identifies children with neurodevelopmental impairment; and 4) trial-based economic evaluations of neonatal interventions can be reliably conducted using clinical data; 5) test methods to link NHS datasets; 6) evaluate parent views of personal data in research Design: Six interrelated work-streams; quarterly extractions of predefined data from neonatal EPR; approvals from the National Research Ethics Service, Health Research Authority Confidentiality Advisory Group, Caldicott Guardians and lead neonatal clinicians of participating NHS Trusts Setting: NHS neonatal unitsParticipants: Neonatal clinical teams; parents of babies admitted to NHS neonatal unitsInterventions: In work-stream 3 we employed the Bayley-III scales to evaluate neurodevelopmental status and the Quantitative Checklist of Autism in Toddlers (Q-CHAT) to evaluate social-communication skills. In work-stream 6 we recruited parents with previous experience of a child in neonatal care to assist in the design of a questionnaire directed at the parents of infants admitted to neonatal units. Data sources: Data extracted from the EPR of admissions to NHS neonatal units Main outcomes and results: We created a National Neonatal Research Database (NNRD) containing a defined extract from real-time, point-of-care, clinician-entered EPR from all NHS neonatal units in England, Wales and Scotland (n=200), establish
Shah PS, Kusuda S, Hakansson S, et al., 2018, Neonatal Outcomes of Very Preterm or Very Low Birth Weight Triplets, PEDIATRICS, Vol: 142, ISSN: 0031-4005
Costeloe K, Turner MA, Padula MA, et al., 2018, Sharing Data to Accelerate Medicine Development and Improve Neonatal Care: Data Standards and Harmonized Definitions, JOURNAL OF PEDIATRICS, Vol: 203, Pages: 437-+, ISSN: 0022-3476
Neu J, Modi N, Caplan M, 2018, Necrotizing enterocolitis comes in different forms: Historical perspectives and defining the disease, SEMINARS IN FETAL & NEONATAL MEDICINE, Vol: 23, Pages: 370-373, ISSN: 1744-165X
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