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  • Journal article
    Lally PJ, Montaldo P, Oliveira V, Swamy RS, Soe A, Shankaran S, Thayyil Set al., 2017,

    Residual brain injury after early discontinuation of cooling therapy in mild neonatal encephalopathy

    , Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 103, Pages: F383-F387, ISSN: 1359-2998

    We examined the brain injury and neurodevelopmental outcomes in a prospective cohort of 10 babies with mild encephalopathy who had early cessation of cooling therapy. All babies had MRI and spectroscopy within 2 weeks after birth and neurodevelopmental assessment at 2 years. Cooling was prematurely discontinued at a median age of 9 hours (IQR 5-13) due to rapid clinical improvement. Five (50%) had injury on MRI or spectroscopy, and two (20%) had an abnormal neurodevelopmental outcome at 2 years. Premature cessation of cooling therapy in babies with mild neonatal encephalopathy does not exclude residual brain injury and adverse long-term neurodevelopmental outcomes. This study refers to babies recruited into the MARBLE study (NCT01309711, pre-results stage).

  • Journal article
    Sánchez-Illana Á, Thayyil S, Montaldo P, Jenkins D, Quintás G, Oger C, Galano J-M, Vigor C, Durand T, Vento M, Kuligowski Jet al., 2017,

    Novel free-radical mediated lipid peroxidation biomarkers in newborn plasma.

    , Analytica Chimica Acta, Vol: 996, Pages: 88-97, ISSN: 0003-2670

    Oxidative stress derived from perinatal asphyxia appears to be closely linked to neonatal brain damage and lipid peroxidation biomarkers have shown to provide predictive power of oxidative stress related pathologies in situations of hypoxia and reoxygenation in the newborn. The objective of this work was to develop and validate of a comprehensive liquid chromatography tandem mass spectrometry approach for the quantitative profiling of 28 isoprostanoids in newborn plasma samples covering a broad range of lipid peroxidation product classes. The method was developed taking into account the specific requirements for its use in neonatology (i.e. limited sample volumes, straightforward sample processing and high analytical throughput). The method was validated following stringent FDA guidelines and was then applied to the analysis of 150 plasma samples collected from newborns. Information obtained from the quantitative analysis of isoprostanoids was critically compared to that provided by a previously developed approach aiming at the semi-quantitative detection of total parameters of fatty acid derived lipid peroxidation biomarkers.

  • Journal article
    Oliveira V, Singhvi DP, Montaldo P, Lally PJ, Mendoza J, Manerkar S, Shankaran S, Thayyil Set al., 2017,

    Therapeutic hypothermia in mild neonatal encephalopathy: a national survey of practice in the UK

    , Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 103, Pages: F388-F390, ISSN: 1359-2998

    Although major cooling trials (and subsequent guidelines) excluded babies with mild encephalopathy, anecdotal evidence suggests that cooling is often offered to these infants. We report a national survey on current cooling practices for babies with mild encephalopathy in the UK. From 74 neonatal units contacted, 68 were cooling centres. We received 54 responses (79%) and included 48 (five excluded due to incomplete data and one found later not to offer cooling). Of these, 36 centres (75%) offered cooling to infants with mild encephalopathy. Although most of the participating units reported targeting 33-34°C core temperature, seven (19%) considered initiating cooling beyond 6 hours of age and 13 (36%) discontinued cooling prior to 72 hours. Babies were ventilated for cooling in two (6%) units and 13 (36%) sedated all cooled babies. Enteral feeding was withheld in 15 (42%) units and reduced below 25% of requirements in eight (22%) units. MRI and neurodevelopmental outcome evaluation were offered to all cooled babies in 29 (80%) and 27 (75%) units, respectively. Further research is necessary to ensure optimal neuroprotection in mild encephalopathy.

  • Journal article
    Thayyil S, Oliveira V, Lally PJ, Swamy R, Bassett P, Chandrasekaran M, Mondkar J, Mangalabharathi S, Benkappa N, Seeralar A, Shahidullah M, Montaldo P, Herberg J, Manerkar S, Kumaraswami K, Kamalaratnam C, Prakash V, Chandramohan R, Bandya P, Mannan MA, Rodrigo R, Nair M, Ramji S, Shankaran S, HELIX Trial groupet al., 2017,

    Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.

    , Trials, Vol: 18, ISSN: 1745-6215

    BACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.

  • Conference paper
    Chalak LF, Prempunpong C, Garfinkle J, Rollins N, Nguyen K-A, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna Get al., 2017,

    PROSPECTIVE STUDY OF INFANTS WITH MILD ENCEPHALOPATHY: PRIME STUDY

    , XXV Biennial Meeting of the International Perinatal Collegium, Publisher: WILEY, Pages: 9-9, ISSN: 0803-5253
  • Journal article
    Chandrasekaran M, Chaban B, Montaldo P, Thayyil Set al., 2017,

    Predictive value of amplitude-integrated EEG (aEEG) after rescue hypothermic neuroprotection for hypoxic ischemic encephalopathy: a meta-analysis

    , Journal of Perinatology, Vol: 37, Pages: 684-689, ISSN: 0743-8346

    Objective:Amplitude-integrated electroencephalography (aEEG) is a useful bedside tool in predicting the neurodevelopmental outcome after neonatal encephalopathy; however, the prognostic accuracy may be altered by rescue hypothermic neuroprotection. The objective of this study is to examine the prognostic accuracy of aEEG for predicting long-term neurodevelopmental outcomes in term newborn infants undergoing therapeutic hypothermia for neonatal encephalopathy.Study Design:We examined all studies (Medline, Cumulative Index to Nursing and Allied Health Literature and the Cochrane Library; 2000 to 2014) comparing aEEG (6, 24, 48 or 72 h) in term encephalopathic babies undergoing therapeutic hypothermia, with neurodevelopmental outcome at 1 year or more. We extracted individual patient data from the eligible studies to calculate prognostic indices with exact confidence intervals (CIs). We considered continuous normal voltage as normal aEEG pattern and discontinuous normal voltage, burst suppression, flat trace and persistently low voltage as abnormal, and defined adverse outcome as death or moderate/severe disability at 1 year.Results:We reviewed a total of 70 articles, 17 of which met the inclusion criteria. Eight studies were excluded and 9 studies (N=520) were included in the meta-analysis. The pooled sensitivity and specificity for an abnormal trace at 6 h of age to predict adverse outcome were 96% (95% CI 91 to 98%) and 39% (95% CI 32 to 46%). The diagnostic odds ratio of an abnormal trace was highest at 48 h (66.9 (95% CI 19.7, 227.2)).Conclusions:A persistantly abnormal aEEG at 48 h or more is associated with an adverse neurodevelopmal outcome. The positive prognostic value of 6 h aEEG is poor and good outcome may occur despite abnormal aEEG. Conversely, a normal 6 h aEEG has a good negative predictive value although do not exclude adverse outcomes.

  • Journal article
    Ahmed MU, Chanwimalueang T, Thayyil S, Mandic DPet al., 2016,

    A multivariate multiscale fuzzy entropy algorithm with application to uterine EMG complexity analysis

    , Entropy, Vol: 19, ISSN: 1099-4300

    The recently introduced multivariate multiscale entropy (MMSE) has been successfully used to quantify structural complexity in terms of nonlinear within- and cross-channel correlations as well as to reveal complex dynamical couplings and various degrees of synchronization over multiple scales in real-world multichannel data. However, the applicability of MMSE is limited by the coarse-graining process which defines scales, as it successively reduces the data length for each scale and thus yields inaccurate and undefined entropy estimates at higher scales and for short length data. To that cause, we propose the multivariate multiscale fuzzy entropy (MMFE) algorithm and demonstrate its superiority over the MMSE on both synthetic as well as real-world uterine electromyography (EMG) short duration signals. Based on MMFE features, an improvement in the classification accuracy of term-preterm deliveries was achieved, with a maximum area under the curve (AUC) value of 0.99.

  • Journal article
    Cawley P, Few K, Greenwood R, Malcolm P, Johnson G, Lally P, Thayyil S, Clarke Pet al., 2016,

    Does magnetic resonance brain scanning at 3.0 Tesla pose a hyperthermic challenge to term neonates?

    , The Journal of Pediatrics, Vol: 175, Pages: 228-230.e1, ISSN: 0022-3476

    Next-generation 3-Tesla magnetic resonance (MR) scanners offer improved neonatal neuroimaging, but the greater associated radiofrequency radiation may increase the risk of hyperthermia. Safety data for neonatal 3-T MR scanning are lacking. We measured rectal temperatures continuously in 25 neonates undergoing 3-T brain MR imaging and observed no significant hyperthermic threat.

  • Journal article
    Montaldo P, Oliveira V, Lally PJ, Chaban B, Atreja G, Kirmi O, Thayyil Set al., 2016,

    Therapeutic hypothermia in neonatal cervical spine injury

    , Archives of Disease in Childhood: Fetal & Neonatal Edition, Vol: 101, Pages: F468-F468, ISSN: 1468-2052
  • Journal article
    Montaldo P, Addison S, Oliveira V, Lally PJ, Taylor AM, Sebire NJ, Thayyil S, Arthurs OJet al., 2016,

    Quantification of Maceration Changes using Post Mortem MRI in Fetuses

    , BMC MEDICAL IMAGING, Vol: 16, ISSN: 1471-2342

    BackgroundPost mortem imaging is playing an increasingly important role in perinatal autopsy, andcorrect interpretation of imaging changes is paramount. This is particularly importantfollowing intra-uterine fetal death, where there may be fetal maceration. The aim of thisstudy was to investigate whether any changes seen on a whole body fetal post mortemmagnetic resonance imaging (PMMR) correspond to maceration at conventionalautopsy.Methods: We performed pre-autopsy PMMR in 75 fetuses using a 1.5 Tesla SiemensAvanto MR scanner (Erlangen, Germany). PMMR images were reported blinded to theclinical history and autopsy data using a numerical severity scale (0 = no macerationchanges to 2 = severe maceration changes) for 6 different visceral organs (total 12).The degree of maceration at autopsy was categorized according to severity on anumerical scale (1 = no maceration to 4 = severe maceration). We also generatedquantitative maps to measure the liver and lung T2.Results: The mean PMMR maceration score correlated well with the autopsymaceration score (R2=0.93). A PMMR score of ≥ 4.5 had a sensitivity of 91%,specificity of 64%, for detecting moderate or severe maceration at autopsy. Liver andlung T2 were increased in fetuses with maceration scores of 3-4 in comparison tothose with 1-2 (liver p=0.03, lung p=0.02).Conclusions: There was a good correlation between PMMR maceration score and theextent of maceration seen at conventional autopsy. This score may be useful ininterpretation of fetal PMMR.

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