scholarly journals Effectiveness of Kangaroo Mother Care in Intubated Preterm Neonates 28 to 36 Weeks Gestational Age, Weighing 600 to 2000 Grams at Birth: A Randomized Controlled Trial

2021 ◽  
Vol 55 (9) ◽  
Author(s):  
Shary May M. Baton ◽  
Maria Esterlita T. Villanueva-Uy ◽  
Socorro De Leon-Mendoza
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Late Onset ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kangaroo Mother Care ◽  
Preterm Neonates ◽  
Control Group ◽  
Low Birth Weight Infants ◽  
Randomized Controlled

Background. Kangaroo Mother Care (KMC) is the standard of care for stable low birth weight infants. Provision of KMC to intubated preterm infants may also be beneficial, but strong evidence is still lacking. Objective. To determine the effectiveness of KMC in decreasing mortality among intubated preterm neonates. Study Design. This is a non-blinded, parallel, non-inferiority randomized controlled trial. Methodology. All intubated, preterm admissions, 28-36 weeks gestation, weighing 600-2000 grams, with respiratory distress were included. They were randomized to the intervention group who received KMC for 2-4 hours daily while intubated and the control group who received care inside an incubator. Participants’ physiologic status – before, during, and after the intervention – was recorded. The primary outcome was mortality. Secondary outcomes included comorbidities, days intubated, and hospital stay. Results. There was a total of 32 patients. The risk of dying in the KMC group (n=16) was significantly reduced by 78% (RR 0.22; 95% CI 0.06 - 0.87 p=0.009). The KMC patients were also less likely to have hypothermia, nosocomial pneumonia, NEC, and late-onset neonatal sepsis (p<0.05). The KMC group had higher blood sugar levels (110 vs. 58, p=0.001) and required fewer days of intubation (3.5 vs.1.5 days, p<0.000) compared to the control group. There was no difference in the duration of the hospital stay. Conclusion. KMC is effective in decreasing mortality among intubated preterm neonates. Other comorbidities and days of intubation were also reduced.

scholarly journals Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3373-3378 ◽  
Author(s):  
Hamideh Abbaspour Kasgari ◽  
Siavash Moradi ◽  
Amir Mohammad Shabani ◽  
Farhang Babamahmoodi ◽  
Ali Reza Davoudi Badabi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Single Centre ◽  
Mazandaran Province ◽  
Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

scholarly journals Effectiveness of Kangaroo Mother Care in Reducing Morbidity and Mortality among Preterm Neonates on Nasal Continuous Positive Airway Pressure: A Randomized Controlled Trial

2021 ◽  
Vol 55 (9) ◽  
Author(s):  
Catherine P. Ricero-Luistro ◽  
Maria Esterlita T. Villanueva-Uy ◽  
Aurora Gloria I. Libadia ◽  
Socorro De Leon-Mendoza
Keyword(s):  
Randomized Controlled Trial ◽  
Continuous Positive Airway Pressure ◽  
Hospital Stay ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Kangaroo Mother Care ◽  
Preterm Neonates ◽  
Randomized Controlled

Background. Prematurity is a major cause of neonatal death. Continuous positive airway pressure (CPAP) is the recognized initial intervention among preterm neonates in respiratory distress. Kangaroo mother care (KMC) may help improve neonatal outcomes. Objective. To determine the effectiveness of KMC in reducing morbidity and mortality among preterm neonates on CPAP via RAM nasal cannula (nCPAP). Methods. A prospective, non-blinded, randomized controlled trial was conducted on eligible preterm neonates requiring nCPAP due to respiratory distress. They were randomly allocated to either KMC (n=35) or conventional care groups (n=35). Outcome measures included duration of nCPAP and oxygen support, physiologic parameters, morbidity, mortality, and length of hospital stay. Results. The durations of nCPAP and oxygen support were both significantly shorter in the KMC group. Morbidities (air leak syndrome, necrotizing enterocolitis, and late-onset sepsis) were also significantly lower in the KMC group. Although the mortality rate and the hospital stay were lower in the KMC group, these were not statistically significant. Conclusion. KMC effectively decreased the duration of nCPAP and oxygen support, as well as the incidence of neonatal morbidities. There were trends towards reduced mortality and length of hospital stay in the neonates who received KMC.

scholarly journals Kangaroo Mother Care versus Incubator in Transporting Stable Preterm Neonates: A Randomized Controlled Trial

2021 ◽  
Vol 55 (9) ◽  
Author(s):  
Renelyn P. Ignacio ◽  
Maria Esterlita T. Villanueva-Uy
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Blood Glucose ◽  
Oxygen Saturation ◽  
Respiratory Rate ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Preterm Neonates ◽  
Control Group ◽  
Randomized Controlled

Background. Transporting preterm neonates soon after birth entails risks. Only one study among many about the beneficial effects of Kangaroo Mother Care (KMC) had cited it as a safe and effective alternative to transport incubators. Objective. To determine if KMC transport could be an alternative to transport incubators by comparing the physiological outcomes of the two transport methods. Methods. This is a parallel non-blinded randomized-controlled trial funded by KMC Foundation, Philippines, Inc, of physiologically stable preterm neonates weighing ≤ 2200 grams delivered at a tertiary government hospital from September 10, 2011, to April 18, 2012. After obtaining written consent from their mothers, participants were randomly assigned to either the intervention or control group. The intervention groups were transported from the delivery room to the NICU while on skin-to-skin contact with the caregiver. In contrast, those in the control group were placed in a transport incubator. Vital signs, oxygen saturation, and blood glucose were measured before transport and upon NICU arrival. Adverse effects were monitored. Data were recorded using a standard database. Results. Ninety-two participants were recruited, forty-six in each arm. Two dropped out. The mean change in heart rate in the KMC transport decreased by 1.6 beats per minute; respiratory rate decreased by 0.18 breaths per minute, the temperature increased by 0.01°C, oxygen saturation decreased by 0.07%, blood glucose decreased by 5.07 mg/dL. The measured physiological parameters were not statistically significant between the two groups. In the KMC transport, there was a decreasing trend in the incidence of hypothermia, hypoglycemia, tachypnea, and tachycardia. Conclusion. There are no significant differences in the heart rate, respiratory rate, temperature, oxygen saturation, and blood glucose levels among preterm neonates on KMC transport compared with preterm neonates on transport incubators, which is the current standard of care. The study showed that KMC transport is equally effective as a transport incubator. Hence, in low-resource settings, KMC transport may be used as a safe and effective neonatal transport.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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