The "Ethical guidelines for biomedical research on human participants" prepared by the Indian Council of Medical Research in 2006 came as a welcome step in the process of regulation of research on human subjects, since clear cut Indian guidelines were absent earlier. The guidelines have been accepted as the standard operating manual by Institutional Ethics Committees (IEC) in India. However, over a period of time, it has become obvious that the guidelines lack clarity in certain areas and require to be revised in the light of experiences of members in the IECs. Some of these problems with the ICMR guidelines have been highlighted in this paper to press for revision of the manual in the light of these experiences.
Background: Children differ in their sleep pattern from adults and within their developmental age groups. Good sleep habits help them in better sleep outcomes. Inadequate sleep can contribute to various health issues. Hence, this study was carried out to find out sleep pattern in children and identify factors affecting it so that suitable measures can be taken to ensure good sleep hygiene in children.Methods: This was a cross-sectional observational study done in children aged 1-12 years. Every 5th child who attended OPD were included. Children who were very sick or had chronic illness or pain were excluded. Details pertaining to sleep was recorded after written parental consent.Results: The total sample size was 650. The mean age was 6.25±3.2 years. The mean bed time and wake up time was 9.18 pm±(1.02) and 6.41 am±(0.85) respectively. The mean night sleep duration was 9.38±1.05 hours. Co-sleeping was 97.5%. Sleep problem was seen in 51.1%. Screen time >2 hours contributed to late bedtime and insomnia. Reduced physical activity/exercise was significantly associated with sleep problems.Conclusions: Sleep problems and poor sleep habits are common among children. Increased screen time and reduced physical activities in children contribute to poor sleep habits and sleep problem.
Background: An important risk factor for simple febrile seizures (SFS) could be iron deficiency anaemia (IDA). Though SFS are benign, a history of seizures amongst children in their infancy is often associated with increased chances of recurrence.Objectives: To gauge the effectiveness of prophylactic iron and folic acid (IFA) supplementation in maintaining normal iron status (NIS) and to reduce the recurrences of SFS in children aged 6-12 months over 1 year of follow up.Method: This study recruited 101 children with SFS. Baseline clinical and laboratory investigations were conducted for all the children. Children with NIS were prescribed biweekly IFA supplementation. Mild, moderate and severe IDA were managed using iron therapy, following which, prophylactic IFA supplementation with biannual deworming was piloted for one year. At the end of one year, serum ferritin levels and complete blood counts were assessed and the frequency of SFS episodes were documented. Data analysis was done using Chi-Square test.Results: Frequency of IDA in the study was 93.1%. After intervention, 63.4% showed NIS and increased serum ferritin levels. Thus, the iron status improved after supplementing IFA for one year. After one year of IFA supplementation it was noted that 81.2% of children were void of SFS.
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