Introduction: Perinatal asphyxia has multisystem involvement, kidneys are most frequently affected. This study was conducted to determine the relation between severity of Hypoxic Ischaemic Encephalopathy (HIE) with acute kidney injury in term neonates. Methods: Retrospective study was done over a period of six months (Sept 2016 to Feb 2017) at Department of Neonatology of a tertiary level maternity hospital. Total 98 cases of Perinatal asphyxia cases which were diagnosed with certain degree of HIE were evaluated for its relation with renal involvement in different stage of HIE. Results: Out of 98 cases of perinatal asphyxia, HIE I was 21%, HIE II was 69% and HIE III was 10%, among which 72% cases had some degree of renal problem. seventy two cases had renal problem, oliguric cases were 41 (57%) among which 33% case had persistent symptoms and associated renal function deterioration. Among 42 cases of deranged RFTs, 40% of cases has persistently deranged RFTs. In comparison to HIE II in HIE III, 22% of cases had one time derangement of RFTs and 33% cases had at least one observation of oliguria, while remaining 45% cases had persistent deterioration of RFTs and urine output, suggesting that progression in HIE stage has significant association with renal dysfunction (p < 0.05). More than half of the cases of HIE III had mortality while 20.3% of HIE II cases had mortality, indicating that the mortality is highly significant with higher HIE grade (p < 0.05). Conclusions: Renal involvement is very common in cases of perinatal asphyxia, and severity of renal involvement increases as the HIE grading increases.
Due to the inherent complex nature of clinical trials, individual’s willingness to participate and hence, enrollment in a clinical trial maybe challenging. When it comes to vaccine clinical trial in children, informed consent needs to be secured from the parents or legally acceptable representatives (LARs). Some of the factors which contribute to hesitancy in taking part in clinical trials are based on the level of education, living standards, part of the world they live, associated burden of disease, fear of different procedures in clinical trial, side effects, limited understanding, limited time, and mistrust with Investigational product. This study included 201 parents/LARs, who approached Kanti Children Hospital site in Kathmandu with the interest to get their children enrolled in a vaccine clinical trial with objectives of describing the reasons for agreeing or disagreeing to participate in the vaccine clinical trial, factors affecting decision making, and finding the major concerns of parents/LARs. The acceptance for the study vaccine was 136 (67.7%) whereas denial was 65 (32.3%). This study showed that age, education level, family structure, advice from family and friends, and medical guidance play important roles in willingness of parents to get their child enrolled in the trial. If a proper counseling is done, fear of blood sampling is not a big factor which is contrary to the belief among clinical researchers. Safety of vaccine, frequency of injections, and cost of vaccine were the main concerns of the parents, which need to be addressed extensively while planning for any clinical trial in children.
Methaemoglobinaemia in a new born is a rare cause of cyanosis. We report a case of a new born presented with cyanosis and with normal cardio-pulmonary system. He was diagnosed as methemoglobinemia due to persistent cyanosis despite administration of oxygen and arterial blood gas collection appeared chocolate brown in colour. As methaemoglobin report was in mild range (11.7%), he was treated symptomatically.
Clinical trials in humans are vital to test safety and efficacy of new interventions and are accompanied with the complexity of related regulatory guidelines, stringent time frame and financial burden particularly when participants are children. Conducting clinical trials in low and middle income countries, where 90% of global diseases occur, increases the complexity as resources, infrastructures, and experience related to clinical trials may be limited in some countries. During the COVID-19 pandemic, due to multiple infection control measures such as social distancing, lock-down of the societies, and increased work load of hospital workers, conducting clinical trials seemed very challenging. Related guidelines and recommendations on clinical trials required updates to adapt the situation for ongoing clinical trials to be continued and new clinical trials to be initiated. In this review report, we described the lessons learnt through our experiences, challenges we faced, and the mitigation measures implemented as a response while conducting a phase III clinical trial on a non-COVID-19 vaccine at a government children’s hospital during the COVID-19 pandemic. We hope this report will contribute in lowering the obstacles to allow the successful completion of future studies, in countries where people live with the burden of vaccine-preventable diseases.
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