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...
Objective:The objective of this study was to evaluate intramedullary spinal cord lesions using magnetic resonance spectroscopy and correlate the results with histo-pathological examination (HPE).Materials and Methods:Approval for this study was obtained from our institute ethical committee. Overall, 50 patients were recruited (29 male and 21 female), with a maximum age of 53 years and minimum age of 7 years. The mean age group of the study was 33 years. Standard magnetic resonance imaging (MRI) spine was done on a Siemens Skyra 3Tesla MRI scanner. MR Spectroscopy (MRS) was performed for all patients with intramedullary spinal lesions after getting written consent. It was performed using single-voxel method. The change in the metabolite peak was observed in each case and the results were compared with HPE. These collected data were analyzed using SPSS 16.0 version. Descriptive statistics, frequency analysis, and percentage analysis were used for categorical variables; and for continuous variables, mean and standard deviation were analyzed. McNemar's test was used to find the significance between conventional MRI MRS. In the above statistical tool, the probability value 0.05 is considered as significant level.Results:From our study, we observed that by applying routine MRI sequences alone, we could only detect around 58% of the cases correctly. However, when MRS was done along with the conventional MR imaging, the number of cases detected significantly increased to 84%. By applying McNemar's test and comparing the conventional MRI and MRS with HPE, it was found that statistically significant difference exists with P value of 0.007.Conclusion:MRS of the spinal cord is a promising tool for research and diagnosis because it can provide additional information complementary to other non-invasive imaging methods. It is an emerging tool and adds new biomarker information for characterization of spinal cord tumors, to differentiate benign from malignant lesions and to prevent unnecessary biopsies and surgeries.
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