Hypothyroidism among Children with Nephrotic Syndrome Admitted to a Tertiary Care Centre.

Introduction: Nephrotic syndrome is a glomerular disease characterized by massive urinary protein loss occurring in children. Proteinuria also leads to loss of thyroid binding globulin affecting thyroid function. This study aimed to find out the prevalence of hypothyroidism among children with nephrotic syndrome admitted to a tertiary care centre. Methods: A descriptive cross-sectional study was conducted among children with nephrotic syndrome admitted to a tertiary care centre from 06 July 2020 to 06 June 2021 after obtaining ethical approval from the Ethical Review Committee. They were tested for free T3, free T4 and TSH. A convenience sampling method was used. The point estimate was calculated at a 90% Confidence Interval. Results: Among 69 children with nephrotic syndrome, the prevalence of hypothyroidism was 49 (71.01%) (62.03-80.00, 90% Confidence Interval). Conclusions: The prevalence of hypothyroidism among children with nephrotic syndrome was higher than other studies done in similar settings. Keywords: children; hypothyroidism; nephrotic syndrome; prevalence.

Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal.

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.

Clinicolaboratory Profile and Treatment Outcome Within Ninety Days After Discharge During Second Wave of Pediatric COVID-19.

BACKGROUND: The second wave of COVID-19 pandemic hit all age groups with different presentations and outcomes. This study aimed to explore the clinical characteristics, investigational findings, hospital outcomes along with a ninety days telephonic follow-up of COVID-19 infection in children. METHODS: A longitudinal descriptive study among COVID-19 RT-PCR positive hospital-admitted children was conducted during the second wave of the pandemic from 15 Mar 2021 to 15 Oct 2021 at Kanti Children's Hospital. Demographics, clinical characteristics, oxygen saturation, comorbidities, need of oxygen, need of ventilator, laboratory investigations, admission to intensive care unit, duration of hospital stay and patient's outcome (improved and discharged or death) were recorded. A follow up at ninety days from discharge was also done via telephonic call to inquire for any illness and hospital admission. RESULTS: Among the 156 admitted children, males and females were 54.5% and 45.5% with a median age of 15 months and Inter quartile range (IQR) of 63. Thirty-six (23.1%) were underweight and 31 (19.9%) had comorbidities. The most common presenting symptoms were fever 115 (73.7%), cough 50 (32.1%) and vomiting 38 (24.4%). The median (IQR) length of hospital stay was 15 (range of 11-20) days. Oxygen use was seen among 35 (22.4%) cases and 36 (23.1%) cases were admitted to the ICU. Ventilator was required for 7 (4.5%) cases. The number of deaths was 9 (5.8%) during hospital stay. After discharge from the hospital during the ninety days follow-up, 117 children had no health problems while 42 reported having some health problems and 5 died after discharge. CONCLUSIONS: In the second wave of the pandemic, only symptomatic children were admitted. Respiratory and gastrointestinal symptoms were common among the admitted cases. The majority of admitted cases had a good outcome and had no other health problems attributable to COVID-19 till ninety days of follow-up.

Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal.

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.