Comparison of the effect of phenobarbital & levetiracetam in the treatment of neonatal abstinence syndrome (NAS) as adjuvant treatment in neonates admitted to the neonatal intensive care unit: a randomized clinical trial.

BACKGROUND: Infants who are born from mothers with substance use disorder might suffer from neonatal abstinence syndrome (NAS) and need treatment with medicines. One of these medicines is phenobarbital, which may cause side effects in long-term consumption. Alternative drugs can be used to reduce these side effects. This study seeks the comparison of the effects of phenobarbital & levetiracetam as adjuvant therapy in neonatal abstinence syndrome. METHODS: This randomized clinical trial was performed in one year from May 2021 until May 2022. The neonates who were born from mothers with substance use disorder and had neonatal abstinence syndrome in Afzalipoor Hospital of Kerman were studied. The treatment started with morphine initially and every four hours the infants were checked. The infants who were diagnosed with uncontrolled symptoms After obtaining informed consent from the parents were randomly divided into two groups and treated with secondary drugs, either phenobarbital or levetiracetam. RESULTS: Based on the obtained results, it was clear that there was no significant difference between the hospitalization time of the two infant groups under therapy (phenobarbital: 18.59 days versus Levetiracetam 18.24 days) (P-value = 0.512). Also, there was no significant difference between both groups in terms of the frequency of re-hospitalization during the first week after discharge, the occurrence of complications, and third treatment line prescription (P-value = 0.644). CONCLUSIONS: Based on the obtained results, like hospitalization duration time (P-value = 0.512) it seems that levetiracetam can be used to substitute phenobarbital in treating neonatal abstinence syndrome. TRIAL REGISTRATION: The current study has been registered in the Iran registry of clinical trials website (fa.irct.ir) on the date 25/2/2022 with registration no. IRCT20211218053444N2.

Comparison of the efficacy of two natural surfactants (BERAKSURF and BLES) in the treatment of respiratory distress syndrome among preterm neonates.

BACKGROUND: The benefit of surfactant replacement therapy for respiratory distress syndrome (RDS) has been demonstrated. However, some surfactants are expensive and usually inaccessible. Consequently, the Iranian Survanta was produced, but its effect on complications and mortality of RDS is unknown. This study aimed to compare the therapeutic outcomes of Iranian surfactant (beraksurf) and BLES (bovine lipid extract surfactant) on RDS treatment among preterm neonates. METHODS: This triple blinded randomized controlled trial study was performed on 128 eligible neonates diagnosed with RDS in Afzalipour hospital in Kerman, Iran. Diagnosis of RDS, gestational age of 28-34 weeks and weight ≥ 1 kg were considered as inclusion criteria. Congenital anomalies such as congenital cyanotic heart diseases, digestive system anomalies and chromosome abnormalities were the exclusion criteria Neonates were randomly assigned into two equal groups: (1) those treated with BLES (n = 64) and (2) those treated with beraksurf (n = 64). Complications including patent ductus arteriosus (PDA), sepsis, intraventricular hemorrhage (IVH), pneumothorax, pulmonary hemorrhage, mortality, and also, the number of days required for invasive mechanical ventilation (using ventilator) and non-invasive continuous positive airway pressure (CPAP) were evaluated for all neonates. The risk ratio (RR) was calculated at 95% of confidence intervals (CI). RESULTS: Compared with BLES group, the RR estimate among neonates in beraksurf group was 0.89 (0.66-1.20) for PDA, 0.71 (0.23-2.13) for IVH, 0.44 (0.14-1.36) for sepsis, 0.35 (0.13-0.93) for pneumothorax, 0.33 (0.12-0.86) for pulmonary hemorrhage, and 0.55 (0.28-1.05) for mortality. CONCLUSIONS: Despite advances in the use of exogenous surfactants for the treatment of neonatal respiratory distress syndrome; There are still some controversial topics in this field. The results obtained in the present study showed that the two types of surfactant (BERAKSURF and BLES) have similar efficacy for the treatment and short-term outcomes in preterm infants with respiratory distress syndrome. Therefore, due to the cost-effectiveness of BRAKSURF compared to BLES, We recommend choosing BERAKSURF in terms of treatment.

Is neonatal phototherapy associated with a greater risk of childhood cancers?

BACKGROUND: Neonatal phototherapy (NNPT) has long been used as an effective and relatively safe method of treating neonatal hyperbilirubinemia. Considering the subsequent evidence of long-term impacts of NNPT such as malignancies, this study was conducted to evaluate the relationship between NNPT and childhood cancers. METHODS: This case-control study assessed 116 children up to 4 years old with every kind of cancer referred to the Oncology department of Afzalipour hospital, Kerman, Iran, from 2011 to 18. Moreover, 116 pediatric patients without cancer hospitalized at the same Center were included after sex and age matching as the control group. The history of phototherapy and its duration were evaluated in these two groups. RESULTS: We found no association between the NNPT and malignancies in children. However, high intensive phototherapy was higher historically among affected cancerous patients than in non-cancerous cases without any statistically significant difference (25% vs 19%; P = 0.26). Maternal educational level and history of maternal infection during pregnancy, which initially appeared to be two factors associated with malignancy in single variable regression analyses, were not significant based on the adjusted models. CONCLUSIONS: The results did not show a positive correlation between NNPT and childhood cancers, which may partly be due to the relatively small sample size of the study. However, some other evidence is worrisome enough that NNPT should not be considered risk-free. Additional multi-centric studies should be undertaken to specify that phototherapy is really safe.

The perspective of medical students regarding the roles and characteristics of a clinical role model.

BACKGROUND: As medical students spend most of their time with their clinical teachers and imitate their roles and characteristics during the school year, it is important to identify the roles and characteristics that they find essential in their role models. These traits play a part in their future professions as doctors. OBJECTIVE: The aim of this study was to determine the perspective of students, interns, and residents regarding the roles and characteristics of a clinical role model. METHODS: In an analytical cross-sectional study, a structured and self-developed questionnaire was completed by 185 medical students at educational hospitals of Kerman University of Medical Sciences during April and May 2015. Participants were selected using convenience sampling method. For data analysis, we used descriptive and inferential statistics. SPSS software version 16 was used as needed. RESULTS: In total, 90 medical students (48.7%), 65 interns (35.1%), and 30 residents (16.2%) participated in this study. Male respondents (n=75) comprised 40.5% and female respondents (n=110) 59.5% of the study sample. The three most important roles of a clinical teacher were organizer role (99.7), teacher role (101.7), and supporter role (109.5) for students, interns, and residents respectively. On the other hand, supporter role (85.4), communicator role (86.4) and organizer role (83.4) were ranked as the least important for students, interns, and residents respectively. There was no significant association among the three batches and the roles of a clinical teacher (p>0.05). Conversely, Females rated the roles of a clinical teacher significantly higher than males (p<0.05). CONCLUSIONS: As teachers are frequently perceived by students as role models in medical schools, great attention should be given to their roles. Teachers must be aware that their roles have an impact on students' professional development and performance.

Comparison of nasal intermittent positive pressure ventilation and nasal continuous positive airway pressure treatments using parametric survival models.

OBJECTIVE: The Cox model is the dominant tool in clinical trials to compare treatment options. This model does not specify any specific form to the hazard function. On the other hand, parametric models allow the researcher to consider an appropriate shape of hazard function for the event of interest. The aim of this article is to compare performance of Cox and parametric models. METHODS: We used data collected in a prospective clinical trial that aimed to compare performance of nasal intermittent positive pressure ventilation (NIPPV) and nasal continuous positive airway pressure (NCPAP) treatments in terms of survival of newborn infants who had respiratory distress syndrome (RDS). Performance of Cox, exponential, Weibull, and log-logistic models were compared in terms of goodness of fit. FINDINGS: Fitting the Cox model, we have seen that infants who received NCPAP were 4.23 (Hazard Ratio= 4.23, 95% Confidence Interval: 1.87-9.59) times more likely to fail than those received NIPPV (P=0.001). Adequacy of the exponential model was rejected. We have seen a decreasing hazard rate over time, in both treatment groups. This decrease was sharper in NCPAP group. Akiake information criterion corresponded to the log-logistic model and was lower than all other models followed by Weibull model. CONCLUSION: Our results demonstrate the benefit of parametric survival models over traditional Cox regression model in terms of modeling of shape of hazard function. We saw a decreasing hazard that confirms the flexibility of parametric models in terms of the modeling of hazard rate.