scholarly journals Packed Cell Transfusion and Feeding Tolerance in Well Preterm Infants: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Mohammad Kazemian ◽  
Minoo Fallahi ◽  
Saeed Hojjat Kashani ◽  
Saleheh Tajalli ◽  
Naeeme Taslimi Taleghani
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Preterm Infants ◽  
Gestational Age ◽  
Intervention Group ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
Significant Difference ◽  
Packed Cell Transfusion ◽  
Feeding Tolerance

Abstract Background: The correlation between necrotizing enteroculitis (NEC) and packed cell transfusion (PCT) has recently been identified. Based on some research, 25–35% of NEC has been linked to transfusion, we planned this study to determine, the association between PCT and feeding tolerance in well preterm newborns.Method: Our study was a clinical trial study in preterm infants admitted to NICU of Mofid Children's Hospital from April 2017 to May 2018.Seventy well premature babies with a birth weight of <1500 grams and gestational age <32 weeks with enteral feeding, who need PCT were enrolled. The eligible patients divided by simple randomization to two groups, in the intervention group (35 patients) the baby's breastfeeding withholding just during the time of PCT and continue as usual after that, but in control groups (35 patients) feeding of neonates is given as usual regardless of PCT. The feeding tolerance during the first 72 hours after transfusion was compared between the two groups. Sick neonates exclude from the study. Data analysis was performed in SPSS version 20.Results: The mean gestational age, birth weights, and postnatal age in the intervention group were 30.13 weeks, 1245.71grams, and 17 days respectively and in the control group were 29.97weeks, 1169.43grams and 15.46 days respectively without any statistically significant difference between them. Except for hemoglobin and hematocrit pre-transfusion, other characteristics of patients were similar. In the evaluation of feeding tolerance after transfusion during 24, 48 and 72 hours, 32(91.2%), 33(94.73%), 34(97.1%) of both groups, had feeding tolerance with no significant difference There were no statistically significant differences between neonates with and without the feeding tolerance in the patients of each group.Conclusion: Our research showed that in well preterm neonates with a good general condition, during PCT, withholding of feeding, isn’t necessary and continued breastfeeding seems to be safe.Trial registration: All ethical considerations of the study were approved by the institutional review board and the research ethics committee at Shahid Beheshti University of Medical Sciences, Tehran, Iran (IR. SBMU.RETECH.1395.1010) and granted ethical approval and the Iranian Registry of Clinical Trial code are IRCT20200419047136N1.Approved by Iranian Registry of Clinical TrialsTrial Id: 47347IRCT Id: IRCT20200419047136N1Registration date: 2020-05-04, 1399/02/15(The link directly for trial registration: https://en.irct.ir/trial/47347)Approved by Research Ethics Committee: IR. SBMU.RETECH.1395.1010

scholarly journals Packed Cell Transfusion and Feeding Tolerance in Healthy Preterm Infants: A Randomized Clinical Tria

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Minoo Fallahi ◽  
Mohammad Kazemian ◽  
Saeed Hojat Kashani ◽  
Saleheh Tajalli ◽  
Naeeme Taslimi
Keyword(s):  
Birth Weight ◽  
Preterm Infants ◽  
Gestational Age ◽  
Neonatal Intensive Care ◽  
Intervention Group ◽  
Preterm Neonates ◽  
Control Group ◽  
Significant Difference ◽  
Packed Cell Transfusion ◽  
Feeding Tolerance

Background: Recently, the correlation between necrotizing enterocolitis (NEC) and packed cell transfusion (PCT) has been identified. Evidence shows that 25 - 35% of NEC cases are associated with PCT. Objectives: this study aimed to determine the association between PCT and feeding tolerance in healthy preterm newborns. Methods: Materials and Methods: This clinical trial was performed on preterm infants, admitted to the neonatal intensive care unit (NICU) of Mofid Children's Hospital, Tehran, Iran, from April 2017 to May 2018. A total of 70 healthy premature infants (birth weight < 1500 g and gestational age < 32 weeks) with enteral feeding, who required PCT, were included in this study. The eligible infants were divided into two groups by simple randomization. In the intervention group (n = 35), breastfeeding was withheld only during PCT and then continued as usual. On the other hand, in the control group (n = 35), feeding was performed as usual, regardless of PCT. Feeding tolerance within the first 72 hours post-transfusion was compared between the two groups. Sick newborns were excluded from the study. Data analysis was performed in SPSS version 20. Results: The mean gestational age, birth weight, and postnatal age of the neonates were 30.13 weeks, 1245.71 g, and 17 days in the intervention group and 29.97 weeks, 1169.43 g, and 15.46 days in the control group, respectively; there was no significant difference between the two groups. Except for pre-transfusion hemoglobin and hematocrit levels, other characteristics of the two groups were similar. Feeding tolerance was reported in 32 (91.2%), 33 (94.73%), and 34 (97.1%) newborns at 24, 48, and 72 hours post-transfusion in both groups, without any significant difference. There was no significant difference between neonates with and without feeding tolerance in either of the groups. Conclusions: According to the present results, withholding feeding during PCT is not necessary in healthy preterm neonates with a good general condition, and continued breastfeeding seems to be a safe option.

scholarly journals The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032549 ◽  
Author(s):  
Bianca Fleur Middleton ◽  
Mark A Jones ◽  
Claire S Waddington ◽  
Margaret Danchin ◽  
Carly McCallum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Ethics Committee ◽  
Northern Territory ◽  
Rotavirus Vaccine ◽  
Additional Dose ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Indigenous Children

IntroductionRotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.Methods and analysisThis Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.Ethics, registration and disseminationEthics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.Trial registration numberNCT02941107; Pre-results.

scholarly journals Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017550
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
Sheau Huey Chen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Care Programme ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionChronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.Methods and analysisAn open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.Ethics and disseminationThe clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.Trial registration numberRegistered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

scholarly journals Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  
Keyword(s):  
At Risk ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
National Implementation ◽  
General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

2021 ◽  
Vol 43 (5) ◽  
pp. 42-44
Author(s):  
Leonardo Tamariz ◽  
Fred J. Hendler ◽  
John M. Wells ◽  
Annette Anderson ◽  
Stephen Bartlett
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

scholarly journals Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048395
Author(s):  
Morag E Taylor ◽  
Chris Todd ◽  
Sandra O'Rourke ◽  
Lindy M Clemson ◽  
Jacqueline CT Close ◽  
...  
Keyword(s):  
Older People ◽  
Research Ethics ◽  
Process Evaluation ◽  
Ethics Committee ◽  
Community Dwelling ◽  
Innovative Technology ◽  
Local Health ◽  
Research Ethics Committee ◽  
Personal Impact ◽  
The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

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