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  • Journal article
    Johnson SM, Vasu V, Marseille C, Hill C, Toussaint P, Battersby Cet al., 2020,

    Validation of transcutaneous bilirubinometry during phototherapy for detection and monitoring of neonatal jaundice in a low-income setting

    , Paediatrics and International Child Health, Vol: 40, Pages: 25-29, ISSN: 2046-9047

    Background Severe neonatal jaundice (SNJ) and associated long term health sequelae are a significant problem in low income countries (LIC) where measurement of total serum bilirubin (TSB) is often unavailable. Transcutaneous bilirubinometry (TcB) provides opportunity for non-invasive, point-of-care monitoring. Few studies have evaluated its agreement with TSB levels during phototherapy in LICs.AimTo determine agreement between TcB and TSB during phototherapy in a Haiti newborn population, and to establish if TcB can be safely used to guide treatment during photother-apy when TSB is unavailable. MethodsA single centre prospective study (February-May 2017) in Cap Haïtien, northern Haiti was conducted. Newborns with clinically detected jaundice, <7 days of age were eligible for inclusion. A TcB device (JM-103) was used to screen for newborn jaundice along with a parallel TSB. A strip of black tape was placed across the sternum during phototherapy and uncovered for subsequent TcB measurements. Phototherapy treatment decisions were based upon UK National Institute of Clinical Excellence (NICE) threshold criteria. Paired TSB and TcB measurements were compared using Bland Altman methods. Results The final analysis included 70 parallel TSB/TcB measurements from 35 infants within the first five days of life. 19 (54.3%) were male; 12 (34.3%) were <35 weeks. 32 (91.4%) were receiving phototherapy. There was good agreement between TSB and TcB. TcB tended to overestimate bilirubin in comparison to TSB; mean difference 11.1 µmol/L (95% CI -10.2, 32.5 µmol/L). However, at higher bilirubin levels (>250 µmol/L), TcB tended to underestimate bilirubin in comparison to TSB and the magnitude of the differ-ence increased. ConclusionIn a LIC setting where serum bilirubin testing is not commonly available, TcB demon-strates good agreement with TSB and can be safely used to guide jaundice treatment dur-ing phototherapy but may lead to overtreatment at lowe
  • Journal article
    Modi N, 2020,

    Votes for a better future

    , ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 105, Pages: 13-14, ISSN: 0003-9888
  • Journal article
    Oliver S, Uhm S, Duley L, Crowe S, David AL, James CP, Chivers Z, Gyte G, Gale C, Turner M, Chambers B, Dowling I, McNeill J, Alderdice F, Shennan A, Deshpande Set al., 2019,

    Top research priorities for preterm birth: results of a prioritisation partnership between people affected by preterm birth and healthcare professionals

    , BMC Pregnancy and Childbirth, Vol: 19, ISSN: 1471-2393

    BACKGROUND: We report a process to identify and prioritise research questions in preterm birth that are most important to people affected by preterm birth and healthcare practitioners in the United Kingdom and Republic of Ireland. METHODS: Using consensus development methods established by the James Lind Alliance, unanswered research questions were identified using an online survey, a paper survey distributed in NHS preterm birth clinics and neonatal units, and through searching published systematic reviews and guidelines. Prioritisation of these questions was by online voting, with paper copies at the same NHS clinics and units, followed by a decision-making workshop of people affected by preterm birth and healthcare professionals. RESULTS: Overall 26 organisations participated. Three hundred and eighty six people responded to the survey, and 636 systematic reviews and 12 clinical guidelines were inspected for research recommendations. From this, a list of 122 uncertainties about the effects of treatment was collated: 70 from the survey, 28 from systematic reviews, and 24 from guidelines. After removing 18 duplicates, the 104 remaining questions went to a public online vote on the top 10. Five hundred and seven people voted; 231 (45%) people affected by preterm birth, 216 (43%) health professionals, and 55 (11%) affected by preterm birth who were also a health professional. Although the top priority was the same for all types of voter, there was variation in how other questions were ranked. Following review by the Steering Group, the top 30 questions were then taken to the prioritisation workshop. A list of top 15 questions was agreed, but with some clear differences in priorities between people affected by preterm birth and healthcare professionals. CONCLUSIONS: These research questions prioritised by a partnership process between service users and healthcare professionals should inform the decisions of those who plan to fund research. Priorities of people affecte
  • Journal article
    Webbe J, Ali S, Sakonidou S, Webbe T, Duffy J, Brunton G, Modi N, Gale Cet 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.
  • Journal article
    Jawad S, Modi N, Prevost AT, Gale Cet 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.
  • Journal article
    Parkinson JRC, Emsley R, Adkins JLT, Longford N, Ozanne SE, Holmes E, Modi Net al., 2019,

    Clinical and molecular evidence of accelerated ageing following very preterm birth

    , Pediatric Research, Vol: 87, Pages: 1005-1010, 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.
  • Journal article
    Lui K, Lee SK, Kusuda S, Adams M, Vento M, Reichman B, Darlow BA, Lehtonen L, Modi N, Norman M, Hakansson S, Bassler D, Rusconi F, Lodha A, Yang J, Shah PS, Marshall P, Schmidt P, Dhawan A, Craven P, de Waal K, Simmer K, Gill A, Pillow J, Stack J, Birch P, Cooke L, Casalaz D, Holberton J, Stewart A, Downe L, Stewart M, Bajuk B, Berry A, Hunt R, Kilburn C, De Paoli T, Bolisetty S, Paradisis M, Rieger I, Koorts P, Kuschel C, Doyle L, Numa A, Carlisle H, Badawi N, Loughran-Fowlds A, Koh G, Davis J, Luig M, Andersen C, Chambers G, Austin N, Lynn A, Darlow B, Edmonds L, Mildenhall L, Buksh M, Battin M, van den Boom J, Bourchier D, Richardson V, Dineen F, Rajadurai VS, Lam S, Fung G, Harrison A, Synnes A, Cieslak Z, Sherlock R, Yee W, Aziz K, Fajardo C, Kalapesi Z, Sankaran K, Daspal S, Seshia M, Alvaro R, Mukerji A, Da Silva O, Nwaesei C, Lee K-S, Dunn M, Lemyre B, Dow K, Pelausa E, Barrington K, Drolet C, Piedboeuf B, Claveau M, Beltempo M, Bertelle V, Masse E, Canning R, Makary H, Ojah C, Monterrosa L, Deshpandey A, Afifi J, Kajetanowicz A, Andersson S, Tammela O, Sankilampi U, Saarela T, Prazad P, Noguchi A, McWan K, Button B, Stratton W, Hamvus A, Raghaven A, Derrick M, Hadley R, Covert R, Lablanc O, Weiss M, Bell A, Shareef M, Silvestri J, Heymann E, Zangen S, Smolkin T, Mimouni F, Bader D, Rothschild A, Strauss Z, Felszer C, Omari H, Tov-Friedman SE, Bar-Oz B, Feldman M, Saad N, Flidel-Rimon O, Weisbrod M, Lubin D, Litmanovitz I, Kugelman A, Shinwell E, Klinger G, Nijim Y, Bin-Nun A, Golan A, Mandel D, Fleisher-Sheffer V, Kohelet D, Bakhrakh L, Hattori S, Shirai M, Ishioka T, Mori T, Amizuka T, Huchimukai T, Yoshida H, Sasaki A, Shimizu J, Nakamura T, Maruyama M, Matsumoto H, Hosokawa S, Taki A, Nakagawa M, Ko K, Uozumi A, Nakata S, Shimazaki A, Yoda T, Numata O, Imamura H, Kobayashi A, Tokuriki S, Uchida Y, Arai T, Ito M, Ieda K, Ono T, Hayashi M, Maki K, Yamakawa M, Kawai M, Fujii N, Shiomi K, Nozaki K, Wada H, Kim T, Tokunaga Y, Takatera A, Oshima T, Sumida H Met 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
  • Journal article
    Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K, Allen M, Allen A, Freimane DA, Aschner J, Ballard R, Belew Y, Bax R, Bellflower B, Bhatt-Mehta V, Blum M, Bonardi C, Bondurant P, Boylan G, Buracchio T, Burckart G, Burnett A, Burnham J, Carlson C, Chen A, Clay B, Cohen A, Connolly E, Connor E, Darsey E, De Lisa R, Degl J, Dempsey E, Diacovo T, Dionne J, Duchon J, Eklund W, Fabbri L, Fielder A, Freilich E, Furst-Recktenwald S, Graham T, Green D, Grogan C, Heiselman D, Hellstrom A, Herold R, Hibbs AM, Hirschfeld S, Brown MH, Holberton J, Iveli P, Jobe A, Kayton A, Kenner C, Kraft W, Kusuda S, Lacaze T, Lewis T, Lui K, Lutsar I, Mangili A, Mangum B, McCune S, McDonald K, McGuire C, McPherson C, Miller T, Ming J, Mitzner A, Modi N, Morrison M, Morsing E, Mulugeta L, Nakamura H, Nelson S, Noel G, Olshansky M, Oschman A, Ozsahin H, Padula M, Peiris V, Koplowitz LP, Pham J, Pilon A, Portman R, Pressler R, Rabe H, Raju T, Roepke DA, Savani R, Schnell P, Segal R, Senterre T, Shah P, Sheridan P, Sherwin C, Singh R, Soll R, Soul J, Spence K, Storari L, Taminiau J, Tseng B, Van Den Anker J, Varga J, Venkataraman P, Vivas N, Walker K, Wilson J, Zajicek A, Zaloga G, Zeldis Set al., 2019,

    Development of a neonatal adverse event severity scale through a Delphi consensus approach

    , ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 104, Pages: 1167-+, ISSN: 0003-9888
  • Journal article
    Kwok TC, Dorling J, Gale C, 2019,

    Early enteral feeding in preterm infants

    , Seminars in Perinatology, Vol: 43, Pages: 1-11, ISSN: 0146-0005

    Early enteral feeding is a potentially modifiable risk factor for necrotising enterocolitis (NEC) and late onset sepsis (LOS), however enteral feeding practices for preterm infants are highly variable. High-quality evidence is increasingly available to guide early feeding in preterm infants. Meta-analyses of randomised trials indicate that early trophic feeding within 48 h after birth and introduction of progressive enteral feeding before 4 days of life at an advancement rate above 24 ml/kg/day can be achieved in clinically stable very preterm and very low birthweight (VLBW) infants, without higher mortality or incidence of NEC. This finding may not be generalisable to high risk infants such as those born small for gestational age (SGA) or following absent/reversed end diastolic flow velocity (AREDFV) detected antenatally on placental Doppler studies, due to the small number of such infants in existing trials. Trials targeting such high-risk preterm infants have demonstrated that progressive enteral feeding started in the first 4 days is safe and does not lead to higher NEC or mortality; however, there is a paucity of data to guide feeding advancement in such infants. There is little trial evidence to support bolus or continuous gavage feeding as being superior in clinically stable preterm infants. Trials that examine enteral feeding are commonly unblinded for technical and practical reasons, which increases the risk of bias in such trials, specifically when considering potentially subjective outcome such as NEC and LOS; future clinical trials should focus on objective, primary outcome measures such as all-cause mortality, long term growth and neurodevelopment. Alternatively, important short-term outcomes such as NEC could be used with blinded assessment.
  • Journal article
    Duffy JMN, Hirsch M, Ziebland S, McManus RJ, Duffy JMN, Brown M, Gale C, Grobman W, Fitzpatrick R, Karumanchi SA, Lucas N, Magee L, Mol B, Stark M, Thangaratinam S, Wilson M, Hooft JV, von Dadelszen P, Williamson PR, Khan KS, Ziebland S, McManus RJet al., 2019,

    Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers

    , BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Vol: 126, Pages: 1482-1490, ISSN: 1470-0328

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