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NCT ID: NCT03854435 Not yet recruiting - Perinatal Asphyxia Clinical Trials

Determination of Heart Rate in Infants Needing Resuscitation at Birth

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Algorithms for neonatal resuscitation adapted to low resource settings include HR evaluation by auscultation or umbilical cord palpation at about one minute of life. Previous studies conducted in high resource settings showed that auscultation of the precordium is more accurate than umbilical palpation to assess HR of healthy infants at birth.The last versions of the American Heart Association and the European Resuscitation Council Guidelines on Neonatal resuscitation suggest that "during resuscitation of term and preterm newborns, the use of 3-lead ECG for the rapid and accurate measurement of the newborn's heart rate may be reasonable". However, this remains a weak recommendation with a very-low-quality evidence. In low resource countries, a stethoscope is rarely available and palpation of the umbilical pulse is the method used for detecting HR. Although this is preferable to other palpation sites (i.e. femo-ral and brachial artery), there is a high likelihood of underestimating HR with palpation of the umbilical pulse in healthy infants. The accuracy of assessing HR by auscultation and umbilical palpation in newborn infants requir-ing resuscitation remains unknown. To the investigator's knowledge, there are not previous studies that have compared the accuracy of HR estima-tion by auscultation vs. umbilical palpation in newborn infants needing resuscitation This study was designed to compare two different methods (auscultation and umbilical cord pal-pation) of HR estimation in newborn infants needing resuscitation, in order to determine which method is most suitable for use in clinical practice.

NCT ID: NCT03837431 Recruiting - Clinical trials for Cutaneous Leishmaniases

Cutaneous Leishmaniasis Diagnostic Study

Start date: February 13, 2019
Study type: Observational

The performance of the CL Detect Rapid test will be tested in individuals with suspected cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a combined reference of microscopy and PCR. Alternative sampling methods will also be evaluated.

NCT ID: NCT03813069 Suspended - Trachoma Clinical Trials

Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

Musca sorbens, a fly that feeds from ocular and nasal discharge on humans, is thought to be the vector of trachoma. We are developing methods of fly control that specifically target this species, in the hope of interrupting Ct transmission. To our knowledge, the use of commercially available insect repellents has never been tested for prevention of Musca sorbens fly-eye contact (i.e. nuisance and landing in the peri-ocular area). Given the likely necessity for prolonged and/or high frequency fly-eye contact for Ct transmission, the reduction of these contacts through the use of fly repellents presents an exciting opportunity for disease control. Here we propose a within-subject, non-masked, trial of the use of commercially available insect repellents against Musca sorbens, with two consecutive participant groups in the laboratory and in the field, and a primary endpoint of measuring the protective efficacy of each repellent product. Repellent products will be chosen from: DEET (N,N-diethyl-3-methylbenzamide), IR3535 (3-[N-butyl-N-acetyl]-aminopropionic acid ethyl ester), Picaridin (2-(2-hydroxyethyl)-1-piperidinecarboxylic acid 1-methylpropyl ester); PMD (para-Menthane-3,8-diol) or permethrin (m-Phenoxybenzyl)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate). Products tested will be either (1) topical repellents, or (2) in long-lasting, plastic formulations of repellents that can be worn on the body (wearable repellent technologies). The insect repellent synergist Vanillin (4-Hydroxy-3-methoxybenzaldehyde) may be added to the long-lasting plastic formulations, to improve the duration of protection.

NCT ID: NCT03775460 Not yet recruiting - Clinical trials for Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

NCT ID: NCT03761459 Enrolling by invitation - Surgery Clinical Trials

Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

Start date: March 20, 2018
Study type: Observational [Patient Registry]

This study evaluates the current surgical practices at Ayder Comprehensive Specialized Hospital in comparison to the World Health Organization's Surgical Unit Based Safety Programme guidelines and aims to determine how deviations from those guidelines are associated with varying rates of surgical site infection incidence in this population. The results of this study will help elucidate risk factors for surgical site infection and prioritize future interventions to decrease the rate of surgical site infection at Ayder Comprehensive Specialized Hospital, as well as other low and middle-income hospitals. The data collected regarding surgical site infection rates will also prove beneficial in measuring outcomes of any interventions that are developed as a result of this study.

NCT ID: NCT03754322 Recruiting - Malaria Clinical Trials

The Impact of Molecular Diagnosis of Malaria With LAMP in Pregnant Women

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Malaria is one of the major public health problems in sub-Saharan Africa. It contributes significantly to maternal and fetal morbidity and mortality in affected countries. The aim of this study is to evaluate the impact of enhanced case detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design. A pilot prospective diagnostic efficacy study will be conducted from October 2018 until October 2019 in pregnant mothers at three sites in Ethiopia. Both symptomatic and asymptomatic first trimester mothers will be included in the study and individually randomized to either standard of care or one of two enhanced cased detection arms using LAMP for malaria. Mothers in the first trimester will be enrolled during a seven month period from October 2018 to October 2019 and then followed until delivery. Given the rate of pregnant mothers at the three sites, we anticipate 500 mothers in total enrolled in the study during the study period. In the first standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisin combination therapies (ACTs) as per national guidelines. In the second (test) arm, mothers will be tested by a commercially available CE-approved LAMP malaria test at each clinic visit in lieu of microscopy. In the third (test) arm, mothers whether symptomatic or asymptomatic will be tested by both microscopy and LAMP for malaria at each clinic visit and treated if positive by either test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcomes are (i) maternal anemia (ii) infant anemia at birth and (iii) fetal birth weight in each of the three arms.

NCT ID: NCT03730805 Active, not recruiting - Khat Abuse Clinical Trials

The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

The leaves of the khat tree (catha edulis) are traditionally chewed in the countries around the Horn of Africa. They contain the amphetamine-like alkaloid cathinone and their use can produce a Substance Use Disorder. The researchers intent to validate an Amharic and an Oromo version of the WHO's ASSIST-linked Brief Intervention among khat-using Ethiopian university students. In an RCT, khat using students of Jimma University with initial motivation to stop or cut down khat use will be randomised to either an intervention or a control group. In the intervention group, the WHO's ASSIST-linked BI will be delivered in a single session by trained local counsellors. In the control group, participants will receive a neuropsychological assessment (Raven's Standard Progressive Matrices, SPM; Raven, 1972). Khat use, the neuropsychological variables and psychiatric symptoms will be assessed before the intervention and two weeks after it. Additionally, the researchers will measure the participants resistance during the session. The control group will receive the intervention after the post test. In order to study state variables that influence brief intervention effectivity, e.g. by increasing or reducing resistance, the researchers randomise subjects in each study arm to several short pre-interventions that are based on Gollwitzer's empirically well established Mindset Theory of Action Phases (for summary: Gollwitzer & Keller, 2016). This means, before delivering the ASSIST-linked BI (intervention group) or before the SPM assessment (controlgroup) a specific psychological state will be induced by a brief writing task that theoretically should affect the openness to the intervention: (1) implemental mindset, (2) deliberative mindset, (3) no mindset induction. The researchers expect that khat use will be reduced more in the intervention condition compared to the control condition and that induced states influence the effectiveness of the intervention.

NCT ID: NCT03681132 Recruiting - Clinical trials for Hepatitis B, Chronic

The Norwegian Nucleoside Analogue Stop Study

Start date: September 20, 2018
Phase: Phase 4
Study type: Interventional

Globally, an estimated 257 million individuals have chronic hepatitis B-virus infection (CHB). In the absence of treatment 15-40% of these will progress to liver cirrhosis and/or hepatocellular carcinoma. Oral antiviral treatment suppresses the virus and improves prognosis, but less than 0.5% per year achieve a "functional cure" (i.e. HBsAg loss). One remaining controversy, therefore, is whether antiviral treatment must continue life-long. Observational studies have assessed stopping antiviral treatment after years of viral suppression; however, HBsAg loss has rarely been seen. But interestingly, a few small trials that chose watchful waiting instead of re-initiation of treatment when reactivation occurred, achieved 40% HBsAg loss during 6 years follow-up. The present proposal is a randomized controlled trial that will assess the safety, efficacy, and cost-effectiveness of treatment discontinuation - and delayed restart - in HBeAg negative CHB. The study is sufficiently powered to address the hypotheses, and a pilot study that demonstrates feasibility has been performed. Patients will be enrolled at 12 Norwegian hospitals, in addition to our collaborating institution in Ethiopia - the largest CHB treatment center in sub-Saharan Africa. If the study shows that discontinuation is safe and effective, it will directly impact both national and international treatment guidelines. Main objective: -To study whether stopping nucleoside analogue (NA) therapy - and delaying re-start - can trigger an immune response and set off a functional cure (viz HBsAg loss) Secondary objectives: - Assess whether stopping NA therapy - and delaying re-start - leads to a higher chance of HBsAg loss - Assess the safety of stopping NA therapy - and delaying re-start - in terms of hepatic decompensation, fibrosis progression, and/or adverse events - Study whether stopping NA therapy - and delaying re-start - leads to a higher chance of sustained off-therapy immune control (low viral load and normal ALT) - Assess the quality of life and cost-effectiveness of stopping NA therapy - and delaying re-start - Identify predictors of HBsAg loss

NCT ID: NCT03639961 Active, not recruiting - Leadership Clinical Trials

The Effect of Integrated Leading, Managing and Governing for Result Model on Maternity Health Services

Start date: May 27, 2017
Phase: N/A
Study type: Interventional

The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia. To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited. Therefore, this study hypothesize that maternity health services are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?

NCT ID: NCT03627156 Recruiting - Counseling Clinical Trials

The Effect of Guided Counseling in Improving Dietary Practice, Nutritional Status and Birth Weight of Pregnant Women

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Poor dietary intake affects maternal wellbeing, fetal growth, and development. However, many pregnant women in Ethiopia have a poor dietary intake. To improve the dietary intake of pregnant women, nutrition education is often given at the community level during a home visit and at the health institution during antenatal care. Yet, there is no evidence on the effect of nutrition education on dietary intake, nutritional status, and birth weight in the study area. Hence, the objective of this study was to evaluate the effect of guided counseling in improving dietary practice, nutritional status and birth weight of pregnant women. A two-arm parallel cluster randomized community trial will be conducted among pregnant women in West Gojjam Zone, Amhara region, Ethiopia from May to March 2019. Baseline data on dietary practice and nutritional status of pregnant women were collected from May to August 2018 (13weeks). Endline data will be collected from October 2018 to March 2019. Guided counseling using the health belief model and theory of planned behavior has been implemented in the intervention arm (11 clusters) for 10 months. Pregnant women were selected using a cluster sampling method. A validated interviewer-administered structured questionnaire has been used for collecting data on the study subjects both at the baseline and after the intervention. Data has been checked, coded and double entered into Epi-Info version 7.2.2 and exported to SPSS version 23 for statistical analysis. The outcome of the study finding will be useful for health and nutrition policymakers and other concerned bodies in decision making and to design effective intervention strategies to improve dietary practices of pregnant women as a result to prevent malnutrition. 19,553 US dollar is needed to conduct the study.