256 results found
Webbe J, Longford N, Uthaya S, et al., Outcomes following early parenteral nutrition use in preterm neonates: Protocol for an observational study, BMJ Open, ISSN: 2044-6055
Caplan MS, Underwood MA, Modi N, et al., 2019, Necrotizing Enterocolitis: Using Regulatory Science and Drug Development to Improve Outcomes., J Pediatr
Modi N, 2019, Votes for a better future., Arch Dis Child
Webbe J, Ali S, Sakonidou S, et al., Inconsistent outcome reporting in large neonatal trials: A systematic review, Archives of Disease in Childhood. Fetal and Neonatal Edition, 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.
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, Draper ES, Abrams KR, et al., 2019, Can we estimate the length of stay of very preterm multiples?, Arch Dis Child Fetal Neonatal Ed
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
Webbe J, Brunton G, Ali S, et al., 2018, Parent, patient and clinician perceptions of outcomes during and following neonatal care: a systematic review of qualitative research, BMJ Paediatrics Open, Vol: 2, ISSN: 2399-9772
Objective Multiple outcomes can be measured in infants that receive neonatal care. It is unknown whether outcomes of importance to parents and patients differ from those of health professionals. Our objective was to systematically map neonatal care outcomes discussed in qualitative research by patients, parents and healthcare professionals and test whether the frequency with which outcomes are discussed differs between groups.Design Systematic review of qualitative literature. The following databases were searched: Medline, CINAHL, EMBASE, PsycINFO and ASSIA from 1997 to 2017. Publications describing qualitative data relating to neonatal care outcomes, reported by former patients, parents or healthcare professionals, were included. Narrative text was analysed and outcomes grouped thematically by organ system. Permutation testing was applied to assess an association between the outcomes identified and stakeholder group.Results Sixty-two papers containing the views of over 4100 stakeholders were identified; 146 discrete outcomes were discussed; 58 outcomes related to organ systems and 88 to other more global domains. Permutation testing provides evidence that parents, former patients and health professionals reported outcomes with different frequencies (p=0.037).Conclusions Parents, patients and health professionals focus on different outcomes when discussing their experience of neonatal care. A wide range of neonatal care outcomes are reported in qualitative research; many are global outcomes relating to the overall status of the infant. The views of former patients and parents should be taken into consideration when designing research; the development of a core outcomes set for neonatal research will facilitate this.
Villeneuve E, Pitt M, Landa P, et al., 2018, A framework to address key issues of neonatal service configuration in England: the NeoNet multimethods study, Health Services and Delivery Research, Vol: 6, ISSN: 2050-4349
BackgroundThere is an inherent tension in neonatal services between the efficiency and specialised care that comes with centralisation and the provision of local services with associated ease of access and community benefits. This study builds on previous work in South West England to address these issues at a national scale.Objectives(1) To develop an analytical framework to address key issues of neonatal service configuration in England, (2) to investigate visualisation tools to facilitate the communication of findings to stakeholder groups and (3) to assess parental preferences in relation to service configuration alternatives.Main outcome measuresThe ability to meet nurse staffing guidelines, volumes of units, costs, mortality, number and distance of transfers, travel distances and travel times for parents.DesignDescriptive statistics, location analysis, mathematical modelling, discrete event simulation and economic analysis were used. Qualitative methods were used to interview policy-makers and parents. A parent advisory group supported the study.SettingNHS neonatal services across England.DataNeonatal care data were sourced from the National Neonatal Research Database. Information on neonatal units was drawn from the National Neonatal Audit Programme. Geographic and demographic data were sourced from the Office for National Statistics. Travel time data were retrieved via a geographic information system. Birth data were sourced from Hospital Episode Statistics. Parental cost data were collected via a survey.ResultsLocation analysis shows that to achieve 100% of births in units with ≥ 6000 births per year, the number of birth centres would need to be reduced from 161 to approximately 72, with more parents travelling > 30 minutes. The maximum number of neonatal intensive care units (NICUs) needed to achieve 100% of very low-birthweight infants attending high-volume units is 36 with existing NICUs, or 48 if NICUs are located wherever there is c
Modi N, Clarke J, McKee M, 2018, Health systems should be publicly funded and publicly provided., BMJ, Vol: 362, ISSN: 0959-8138
Persson M, Shah PS, Rusconi F, et al., 2018, Association of Maternal Diabetes With Neonatal Outcomes of Very Preterm and Very Low-Birth-Weight Infants An International Cohort Study, JAMA PEDIATRICS, Vol: 172, Pages: 867-875, ISSN: 2168-6203
Wong HS, Cowan FM, Modi N, et al., 2018, Validity of neurodevelopmental outcomes of children born very preterm assessed during routine clinical follow-up in England, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 103, Pages: F497-F484, ISSN: 1359-2998
OBJECTIVE: To determine the validity of assessing and recording the neurodevelopmental outcome of very preterm infants during routine clinical follow-up in England. DESIGN: Children born <30 weeks gestation, attending routine clinical follow-up at post-term ages 20-28 months, were recruited. Data on neurodevelopmental outcomes were recorded by the reviewing clinician in a standardised format in the child's electronic patient record, based on a set of key questions designed to be used without formal training or developmental testing. Using a predefined algorithm, each participant was classified as having 'no', 'mild/moderate' or 'severe' impairment in cognitive, communication and motor domains. All participants also received a research assessment by a single assessor using the Bayley Scales of Infant Development, third edition (Bayley-III). The sensitivity and specificity of routine data in capturing impairment (any Bayley-III score <85) or severe impairment (any Bayley-III score <70) was calculated. RESULTS: 190 children participated. The validity of routine assessments in identifying children with no impairment and no severe impairment was high across all domains (specificities 83.9%-100.0% and 96.6%-100.0%, respectively). However, identification of impairments, particularly in the cognitive (sensitivity 69.7% (55.1%-84.3%)) and communication (sensitivity (53.2% (42.0%-64.5%)) domains, was poor. CONCLUSIONS: Neurodevelopmental status determined during routine clinical assessment lacks adequate sensitivity in cognitive and communication domains. It is uncertain whether this reflects the assessment or/and the recording of findings. As early intervention may improve education and social outcomes, this is an important area for healthcare quality improvement research.
Battersby C, Statnikov Y, Santhakumaran S, et al., 2018, The United Kingdom National Neonatal Research Database: a validation study, PLoS ONE, ISSN: 1932-6203
BackgroundThe National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy.MethodsWe determined population coverage of the NNRD in 2008–2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes.ResultsThe NNRD holds complete population data for England for infants born alive from 25+0 to 31+6 (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD dat
Molloy EJ, Gale CRK, Marsh M, et al., Developing core outcome set for women’s, newborn, and child health: the CROWN Initiative, Pediatric Research, ISSN: 0031-3998
Modi N, 2018, A radical proposal: to promote children's wellbeing give them the vote This straightforward change might ensure that child friendly policies get political attention, BMJ-BRITISH MEDICAL JOURNAL, Vol: 361, ISSN: 1756-1833
Winch R, McColgan MP, Sparrow E, et al., 2018, Public and patient involvement in child health research and service improvements: a survey of hospital doctors, BMJ Paediatrics Open, Vol: 2, ISSN: 2399-9772
Objectives: To determine whether paediatricians are supported by their organisations to encourage patient and public involvement (PPI) in research activities and clinical improvement work, the challenges they face and how they think these could be addressed by the Royal College of Paediatrics and Child Health (RCPCH). Design: A survey. Setting: UK consultant paediatricians and staff associate specialist and specialty (SAS) doctors who are members of RCPCH. Main outcome measures: The proportion of respondents who said that PPI was central to research and service improvements in their organisation, the type of local support for PPI activity, challenges in undertaking PPI and the support members wanted from RCPCH. Results: There was a response rate of 44.4% (n=1924). In their organisation, 29.1% of respondents stated PPI was central to research and 36.1% to service improvement; 46% were unaware of support for PPI and 15% said there was no support. The main challenges for PPI activity were a lack of clinician time, local support and funding. Respondents wanted RCPCH to advocate for protected time for PPI, provide access to PPI groups and deliver guidance and training. Conclusions: The majority of paediatricians feel unsupported to undertake PPI activity by their local organisation. The RCPCH has a key role to enable all paediatricians to work with children, young people and their carers to improve the quality of research and clinical services as demonstrated by RCPCH's ongoing activity in these crucial and important areas.
Helenius K, Sjörs G, Shah PS, et al., 2018, Survival in very preterm infants: An international comparison of 10 national neonatal networks, Obstetrical and Gynecological Survey, Vol: 73, Pages: 187-189, ISSN: 0029-7828
Modi N, 2018, The case for child health, ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 103, Pages: 316-318, ISSN: 0003-9888
Seaton SE, Barker L, Draper ES, et al., 2018, Estimating neonatal length of stay for babies born very preterm, Archives of Disease in Childhood. Fetal and Neonatal Edition, 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.
Battersby C, Mousinho RMA, Longford N, et al., 2018, Use of pasteurised human donor milk across neonatal networks in England, EARLY HUMAN DEVELOPMENT, Vol: 118, Pages: 32-36, ISSN: 0378-3782
ObjectivesTo describe the use of pasteurised human donor milk (pHDM) in England and the influence of a human milk bank in the network.DesignProspective observational studySettingAll 163 neonatal units (23 networks) in England 2012–2013.PatientsPreterm infants born at <32 weeks gestational age (GA).Main outcome measuresProportion of infants and care-days fed pHDM during the first 30 postnatal days by networkMethodsWe extracted daily patient-level data from the National Neonatal Research Database (NNRD). We fitted a logistic regression of pHDM exposure on the presence of a pHDM bank within the network, with GA, BW z score and network as covariates. Significance was assessed by the likelihood ratio (chi-squared) test.ResultsData for 13,463 infants were included in the study. Across the networks, the proportion (95%CI) of infants ranged from 2.0% (1.0, 3.0) to 61.0% (57.4%, 64.6%), and the proportion of care-days in which pHDM was fed from 0.08% (0.04%, 0.10%) to 21.9% (19.9%, 24.0%). In three networks <5%, and in seven networks >30% of infants received any pHDM. Variation in the use of pHDM across networks remained significant after adjustment for presence of a human milk bank within the network and all covariates (p < 0.001).ConclusionsWide variation of pHDM use in England is not fully explained by presence of a pHDM bank or patient characteristics. This suggests clinical uncertainty about the use of pHDM.
Battersby CWS, Santhalingam T, Costeloe K, et al., 2018, Incidence of neonatal Necrotising Enterocolitis in high income countries: a systematic review, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 103, Pages: F182-F189, ISSN: 1359-2998
Objective To conduct a systematic review of neonatal necrotising enterocolitis (NEC) rates in high-income countries published in peer-reviewed journals.Methods We searched MEDLINE, Embase and PubMed databases for observational studies published in peer-reviewed journals. We selected studies reporting national, regional or multicentre rates of NEC in 34 Organisation for Economic Co-operation and Development countries. Two investigators independently screened studies against predetermined criteria. For included studies, we extracted country, year of publication in peer-reviewed journal, study time period, study population inclusion and exclusion criteria, case definition, gestation or birth weight-specific NEC and mortality rates.Results Of the 1888 references identified, 120 full manuscripts were reviewed, 33 studies met inclusion criteria, 14 studies with the most recent data from 12 countries were included in the final analysis. We identified an almost fourfold difference, from 2% to 7%, in the rate of NEC among babies born <32 weeks’ gestation and an almost fivefold difference, from 5% to 22%, among those with a birth weight <1000 g but few studies covered the entire at-risk population. The most commonly applied definition was Bell’s stage ≥2, which was used in seven studies. Other definitions included Bell’s stage 1–3, definitions from the Centers for Disease Control and Prevention, International Classification for Diseases and combinations of clinical and radiological signs as specified by study authors.Conclusion The reasons for international variation in NEC incidence are an important area for future research. Reliable inferences require clarity in defining population coverage and consistency in the case definition applied.
Binder C, Longford N, Gale CRK, et al., 2018, Body composition following necrotising enterocolitis in preterm infants, Neonatology, Vol: 113, Pages: 242-248, ISSN: 1661-7800
Background: The optimal nutritional regimen for preterm infants, including those that develop necrotising enterocolitis (NEC), is unknown. Objective: The objective here was to evaluate body composition at term in infants following NEC, in comparison with healthy infants. The primary outcome measure was non-adipose tissue mass (non-ATM). Methods: We compared body composition assessed by magnetic resonance imaging at term in infants born <31 weeks of gestational age that participated in NEON, a trial comparing incremental versus immediate delivery of parenteral amino acids on non-ATM, and SMOF versus intralipid on intrahepatocellular lipid content. There were no differences in the primary outcomes. We compared infants that received surgery for NEC (NEC-surgical), infants with medically managed NEC (NEC-medical), and infants without NEC (reference). Results: A total of 133 infants were included (8 NEC-surgical; 15 NEC-medical; 110 reference). In comparison with the reference group, infants in the NEC-surgical and NEC-medical groups were significantly lighter [adjusted mean difference (95% CI) NEC-surgical: –630 g (–1,010, –210), p = 0.003; NEC-medical: –440 g (–760, –110), p = 0.009] and the total adipose tissue volume (ATV) was significantly lower [NEC-surgical: –360 cm3 (–516, –204), p < 0.001; NEC-medical: –127 cm3 (–251, –4); p = 0.043]. There were no significant differences in non-ATM [adjusted mean difference (95% CI) NEC-surgical: –46 g (–281, 189), p = 0.70; NEC-medical: –122 g (–308, 63), p = 0.20]. Conclusion: The lower weight at term in preterm infants following surgically and medically managed NEC, in comparison to preterm infants that did not develop the disease, was secondary to a reduction in ATV. This suggests that the nutritional regimen received was adequate to preserve non-ATM but not to support the normal third-trimester deposition of adipose tissue
Webbe J, Modi N, Gale C, 2018, Core quality and outcome measures for pediatric health, JAMA Pediatrics, Vol: 172, Pages: 299-300, ISSN: 2168-6203
Beltempo M, Isayama T, Vento M, et al., 2018, Respiratory Management of Extremely Preterm Infants: An International Survey, NEONATOLOGY, Vol: 114, Pages: 28-36, ISSN: 1661-7800
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