Summary Background Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. Methods We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18–22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , NCT02387385 . Findings We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87–1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention. Interpretatio...
Previous studies report that the COVID-19 pandemic has a negative effect on the psychological wellbeing of medical students. We aimed to determine the psychological impact of COVID-19 and its associated factors among a cohort of Sri Lankan medical students, using online versions of a demographic questionnaire and the validated Sinhala and Tamil versions of the DASS-21. Of the 418 students, majority were females, aged between 20-25 years. In the study group, 40 (9.6%), 105 (25.1%) and 7 (1.6%) of participants scored above the cut-offs for the depression, anxiety and stress subscales of the DASS-21 respectively. The COVID-19 pandemic appears to be associated with a negative impact as measured by the DASS-21 scale among this group of medical students.
Background and Objectives: Tinnitus is a common and disabling condition that largely remains undertreated in Sri Lanka. Currently, standardized tools that assess and monitor the treatment of tinnitus or the distress it causes are unavailable in either of the two main vernacular languages prevalent in Sri Lanka. The Tinnitus Handicap Inventory (THI) is used internationally to measure tinnitus-induced distress and to monitor treatment efficacy. In this study, we validated the Sinhala version of the THI (THI-Sin).Subjects and Methods: The THI was translated into Sinhala and back translated into English and finalized by independent translators. The THI-Sin questionnaire and the 12-item General Health Questionnaire (GHQ-12) and Visual Analog Scale of tinnitus annoyance (VAS) were administered to 122 adults who visited the otolaryngology clinic of Colombo North Teaching Hospital, Ragama, Sri LankaResults: THI-Sin scores showed satisfactory internal consistency (Cronbach’s α=0.902) and were significantly correlated with the GHQ-12 and VAS scores. Factor analysis of the THI-Sin confirmed a three-factorial structure, which did not correspond to the original THI subscales.Conclusions: We observed significant reliability and validity of the THI-Sin tool for evaluation of tinnitus-induced handicaps among the Sinhalese-speaking population of Sri Lanka.
ObjectiveTinnitus is a common and debilitating health condition. It is often associated with psychiatric morbidity. This important health concern has not been studied previously in Sri Lanka. We aimed to determine the prevalence of psychological morbidity, resilience and their correlates among a cohort of Sri Lankan patients with tinnitus. MethodsA descriptive cross-sectional study was conducted among attendees of otolaryngology clinics in three Sri Lankan hospitals, using a specially designed questionnaire. Resilience was defined as absence of psychological morbidity and functional impairment. ResultsOf the 200 patients included in the study, 82.5% reported functional impairment due to tinnitus. The majority of participants were found to have depression (61.5%). Sleep disturbance, feeling exhausted, loudness of tinnitus and functional impairment were significantly associated with psychological morbidity. Only 12% of participants were resilient and it was associated with mind-fulness and ability to distract self. ConclusionsTinnitus is a distressing illness associated with a significant functional impairment and psychiatric morbidity. We discuss the implication of this study for clinical practice.
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