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Journal articleEmbleton ND, Sproat T, Uthaya S, et al., 2023,
Effect of an Exclusive Human Milk Diet on the Gut Microbiome in Preterm Infants A Randomized Clinical Trial
, JAMA NETWORK OPEN, Vol: 6, ISSN: 2574-3805- Author Web Link
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- Citations: 2
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Journal articleSmith ER, Oakley E, Grandner GW, et al., 2023,
Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: A sequential, prospective meta-analysis
, American Journal of Obstetrics and Gynecology, Vol: 228, Pages: 161-177, ISSN: 0002-9378OBJECTIVE: This sequential, prospective meta-analysis (sPMA) sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to: disease severity, maternal morbidities, neonatal mortality and morbidity, adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sPMA via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. STUDY APPRAISAL AND SYNTHESIS METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a two-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (pre-existing diabetes, hypertension, cardiovascular disease) versus those without were at higher risk for COVID-19 severity and pregnancy health outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% CI: 1.12, 2.71) more likely to be admitted to the ICU. Pregnant women who were underweight before pregnancy were at higher risk of ICU admission (RR 5.53, 95% CI: 2.27, 13.44), ventilation (RR 9.36, 95% CI: 3.87, 22.63), and pregnancy-related death (RR 14.10, 95% CI: 2.83, 70.36). Pre-pregnancy obesity was also a risk factor for severe COVID-19 outcomes including ICU admission (RR 1.81, 95% CI: 1.26,2.60), ventilation (RR 2.05, 95% CI: 1.20,3.51), any critical care (RR 1.89, 95% CI: 1.28,2.77), and pneumonia (RR 1.66, 95% CI: 1.18,2.33). Anemic pregnant women with COVID-19 also had in
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Journal articleLammons W, Moss R, Bignell C, et al., 2023,
Involving multiple stakeholders in assessing and reviewing a novel data visualization tool for a national neonatal data asset
, BMJ Health & Care Informatics, Vol: 30, Pages: 1-7, ISSN: 2632-1009Objectives We involved public and professional stakeholders to assess a novel data interrogation tool, the Neonatal Health Intelligence Tool, for a National Data Asset, the National Neonatal Research Database.Methods We recruited parents, preterm adults, data managers, clinicians, network managers and researchers (trialists and epidemiologists) for consultations demonstrating a prototype tool and semi-structured discussion. A thematic analysis of consultations is reported by stakeholder group.Results We held nine on-line consultations (March–December 2021), with 24 stakeholders: parents (n=8), preterm adults (n=2), data managers (n=3), clinicians (n=3), network managers (n=2), triallists (n=3) and epidemiologists (n=3). We identified four themes from parents/preterm adults: struggling to consume information, Dads and data, bring data to life and yearning for predictions; five themes from data managers/clinicians/network managers: benchmarking, clinical outcomes, transfers and activity, the impact of socioeconomic background and ethnicity, and timeliness of updates and widening availability; and one theme from researchers: interrogating the data.Discussion Other patient and public involvement (PPI) studies have reported that data tools generate concerns; our stakeholders had none. They were unanimously supportive and enthusiastic, citing visualisation as the tool’s greatest strength. Stakeholders had no criticisms; instead, they recognised the tool’s potential and wanted more features. Parents saw the tool as an opportunity to inform themselves without burdening clinicians, while clinicians welcomed an aid to explaining potential outcomes to parents.Conclusion All stakeholder groups recognised the need for the tool, praising its content and format. PPI consultations with all key groups, and their synthesis, illustrated desire for additional uses from it.
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Journal articleLugg-Widger FV, Barlow C, Cannings-John R, et al., 2023,
The practicalities of adapting UK maternity clinical information systems for observational research: experiences of the POOL study
, International Journal of Population Data Science, Vol: 8, ISSN: 2399-4908BackgroundUsing routinely collected clinical data for observational research is an increasingly important method for data collection, especially when rare outcomes are being explored. The POOL study was commissioned to evaluate the safety of waterbirth in the UK using routine maternity and neonatal clinical data. This paper describes the design, rationale, set-up and pilot for this data linkage study using bespoke methods.MethodsClinical maternity information systems hold many data items of value for research purposes, but often lack specific data items required for individual studies. This study used the novel method of amending an existing clinical maternity database for the purpose of collecting additional research data fields. In combination with the extraction of existing data fields, this maximised the potential use of existing routinely collected clinical data for research purposes, whilst reducing NHS staff data collection burden.Wellbeing Software® provider of the Euroking® Maternity Information System, added new study specific data fields to their information system, extracted data from participating NHS sites and transferred data for matching with the National Neonatal Research Database to ascertain outcomes for babies admitted to neonatal units. Study set-up processes were put in place for all sites. The data extraction, linkage and cleaning processes were piloted with one pre-selected NHS site.ResultsTwenty-six NHS sites were set-up over 27 months (January 2019 - April 2021). Twenty-four thousand maternity records were extracted from the one NHS site, pertaining to the period January 2015 to March 2019. Data field completeness for maternal and neonatal primary outcomes were mostly acceptable. Neonatal identifiers flowed to the National Neonatal Research Database for successful matching and linkage between maternity and neonatal unit records.DiscussionPiloting the data extraction and linkage highlighted the need for additional governance arrangem
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Journal articleSmith ER, Oakley E, Grandner GW, et al., 2023,
Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis
, BMJ Global Health, Vol: 8, Pages: 1-19, ISSN: 2059-7908Introduction Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies.Methods We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale.Results We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection—as compared with uninfected pregnant women—were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias.Conclusions This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth r
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Journal articleMitchell EJ, Meakin G, Anderson J, et al., 2022,
The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age)
, Trials, Vol: 23, Pages: 1-12, ISSN: 1745-6215BackgroundIn the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initiating full milk feeds for preterm infants due to fears of necrotising enterocolitis (NEC). There is now evidence to dispute this fear. Small studies have shown that feeding preterm infants full milk feeds enterally from birth could result in a shorter length of hospital stay, which is important to parents, clinicians and NHS services without increasing the risk of NEC. This trial aims to investigate whether full milk feeds initiated in the first 24 h after birth reduces the length of hospital stay in comparison to introduction of gradual milk feeding with IV fluids or parenteral nutrition.MethodsFEED1 is a multi-centre, open, parallel group, randomised, controlled superiority trial of full milk feeds initiated on the day of birth versus gradual milk feeds for infants born at 30+0 to 32+6 (inclusive) weeks gestation. Recruitment will take place in around 40 UK neonatal units. Mothers will be randomised 1:1 to full milk feeds, starting at 60 ml/kg day, or gradual feeds, as per usual local practice. Mother’s expressed breast milk will always be the first choice of milk, though will likely be supplemented with formula or donor breast milk in the first few days. Feeding data will be collected until full milk feeds are achieved (≥ 140 ml/kg/day for 3 consecutive days). The primary outcome is length of infant hospital stay. Additional data will be collected 6 weeks post-discharge. Follow-up at 2 years (corrected gestational age) is planned. The sample size is 2088 infants to detect a between group difference in length of stay of 2 days. Accounting for multiple births, this requires 1700 women to be recruited. Primary analysis will compare the length of
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Journal articleShah PS, Isayama T, Helenius KK, et al., 2022,
International network for evaluating outcomes of neonates: outputs and future directions
, PEDIATRIC MEDICINE, Vol: 5 -
Journal articleShen R, Embleton N, Forman J, et al., 2022,
Early antibiotic use and incidence of necrotising enterocolitis in very preterm infants: a protocol for a UK based observational study using routinely recorded data
, BMJ Open, Vol: 12, ISSN: 2044-6055Introduction Necrotising enterocolitis (NEC) remains a major contributor to preterm mortality and morbidity. Prolonged duration of antibiotic therapy after delivery is associated with later NEC development but recent evidence suggests that absence of antibiotic treatment after delivery may also increase NEC risk. We will explore this controversy using a large pre-existing dataset of preterm infants in the UK.Methods and analysis: This is a retrospective cohort study using data from UK National Neonatal Research Database (NNRD) for infants born 1 January 2012 to 31 December 2020. Eligible infants will be <32 weeks gestation, alive on day 3. Primary outcome is development of severe NEC, compared in infants receiving early antibiotics (days 1–2 after birth) and those not. Subgroup analysis on duration of early antibiotic exposure will also occur. Secondary outcomes are: late onset sepsis, total antibiotic use, predischarge mortality, retinopathy of prematurity, intraventricular haemorrhage, bronchopulmonary dysplasia, focal intestinal perforation and any abdominal surgery. To address competing risks, incidence of death before day 7, 14 and 28 will be analysed. We will perform logistic regression and propensity score matched analyses. Statistical analyses will be guided by NEC risk factors, exposures and outcome presented in a causal diagram. These covariates include but are not limited to gestational age, birth weight, small for gestational age, sex, ethnicity, delivery mode, delivery without labour, Apgar score, early feeding and probiotic use. Sensitivity analyses of alternate NEC definitions, specific antibiotics and time of initiation will occur.Ethics and dissemination: We will use deidentified data from NNRD, which holds permissions for the original data, from which parents can opt out and seek study-specific research ethics approval. The results will help to determine optimal use of early antibiotics for very preterm infants.Implications: This data will
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Journal articleModi N, Bhalotra S, Bustreo F, et al., 2022,
We must value and safeguard human health for a sustainable future
, BMJ-BRITISH MEDICAL JOURNAL, Vol: 379, ISSN: 0959-535X -
Journal articleRees P, Callan C, Chadda K, et al., 2022,
Preterm brain injury and neurodevelopmental outcomes: a meta-analysis
, Pediatrics, Vol: 150, Pages: 1-15, ISSN: 0031-4005Context:Preterm brain injuries are common; neurodevelopmental outcomes following contemporary neonatal care are continually evolving.Objective:To systematically review and meta-analyze neurodevelopmental outcomes among preterm infants after intraventricular hemorrhage (IVH) and white matter injury (WMI). Data Sources:Published and grey literature were searched across 10 databases between 2000-2021Study Selection:Observational studies reporting 3-year neurodevelopmental outcomes for preterm infants with IVH or WMI compared to preterm infants without injury.Data extraction:Study characteristics, population characteristics, and outcome data were extracted.Results:38 studies were included. There was an increased adjusted risk of moderate-severe neurodevelopmental impairment after IVH grade 1-2 (aOR 1.35 [95% CI 1.05, 1.75]) and IVH grade 3-4 (aOR 4.26 [3.25, 5.59]). Children with IVH grade 1-2 had higher risks of cerebral palsy (OR 1.76 [1.39, 2.24)], cognitive (OR 1.79 [1.09, 2.95]), hearing (OR 1.83 CI [1.03. 3.24]), and visual impairment (OR 1.77 [1.08, 2.9]). Children with IVH grade 3-4 had markedly higher risks of cerebral palsy (OR 4.98 [4.13, 6.00)], motor (OR 2.7 [1.52, 4.8)], cognitive (OR 2.3 [1.67, 3.15)], hearing (OR 2.44 [1.42, 4.2)), and visual impairment (OR 5.42 [2.77, 10.58)). Children with WMI had much higher risks of cerebral palsy (OR 14.91 [7.3, 30.46), motor (OR 5.3 [3, 9.36)], and cognitive impairment (OR 3.48 [2.18, 5.53)).Limitations:Heterogeneity of outcome data.Conclusions:Mild IVH, severe IVH, and WMI are associated with adverse neurodevelopmental outcomes. Utilization of core outcomes sets and availability of open-access study data would improve our understanding of the nuances of these outcomes.
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