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Malnutrition clinical trials

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NCT ID: NCT02572063 Terminated - Malnutrition Clinical Trials

Omics4Aging: Stratification of Frailty Population

ProAge
Start date: November 15, 2015
Phase:
Study type: Observational

The overall objective of the study is to stratify a frailty population based on nutrients profiling (amino acids, vitamins, minerals, fatty acids) and metabolic profiling (low molecular weight metabolites in urine and plasma) at baseline.

NCT ID: NCT02564159 Terminated - Critical Illness Clinical Trials

Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit

MALICUS
Start date: October 30, 2015
Phase: N/A
Study type: Interventional

Malnutrition is a major risk factor for morbidity and mortality of patients managed in intensive care unit. Early recognition and treatment of adult malnutrition are recommended in acute care settings especially for patients requiring mechanical ventilation. Biochemical indicators like serum concentrations of albumin and prealbumin (transthyretin) have a tradition of being used as markers of nutritional status but remains influenced by nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound method has gained interest for screening and follow-up of muscle weakness at the bedside in critically ill patients. In this light, the MALICUS project aims to investigate the validity of ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit. Skeletal muscle is central to cytokine regulation and it contributes 85% of total body glucose clearance. Some research findings suggest that muscle wasting is a smoldering inflammatory state partially driven by cytokines and oxidative stress but these conclusions need to be investigated in context of critically ill patients and perioperative settings. The investigators search to determine impact of inflammatory biomarkers (IL-1, IL-6 and TNF-α) and oxidative stress (evaluated by quantifying the global anti-oxidative defenses in patient with an original method (Patrol® test) based on the use of excited molecular oxygen (singlet oxygen) as a source of ROS on erosion of lean body mass measure with quadriceps muscle ultrasound. Consequently, in an ancillary study of the MALICUS project, the investigators wish to investigate interaction between acute inflammation and muscle wasting.

NCT ID: NCT02484183 Terminated - Pneumonia Clinical Trials

CPAP Improving Mortality for Pneumonia in African Children Trial

IMPACT
Start date: June 23, 2015
Phase: N/A
Study type: Interventional

Pneumonia mortality rates in African countries like Malawi are high and increased further in children -exposed or infected with human immunodeficiency virus (HIV) as well as those that are severely malnourished or severely hypoxemic. Treatment innovations are needed. Bubble continuous positive airway pressure (bCPAP) improves oxygenation and ventilation and is a simple, relatively inexpensive adaptation of conventional continuous positive airway pressure potentially suitable for low-resource settings. bCPAP has been demonstrated to improve outcomes in neonates less than 1 month of age. Recently, a limited number of hospitals are using bCPAP to escalate pneumonia care for older African children failing standard treatment with antibiotics and oxygen. Supportive evidence for this approach is observational only. Quality randomized studies comparing bCPAP versus a standard-of-care control group that includes low-flow oxygen therapy and using a primary endpoint of mortality are not available in low-resource settings including high prevalence HIV countries like Malawi. Demonstrating a mortality benefit with bCPAP is needed to support further investment and scale up of bCPAP in the care of older Malawian children 1-59 months of age with World Health Organization (WHO) severe pneumonia complicated by HIV and/or malnutrition or severe hypoxemia. With the full support of the Malawi Ministry of Health and in collaboration with external experts from Lilongwe Medical Relief Trust and Cincinnati Children's Hospital Medical Center investigators plan to address this critical evidence gap by conducting a randomized controlled study determining bCPAP outcomes, compared to the currently recommended standard of care endorsed by the WHO and Malawi national pneumonia guidelines, in hospitalized Malawian children with WHO-defined severe pneumonia complicated by a co-morbidity ((1) HIV-infection, (2) HIV-exposure without infection, (3) severely malnourished) or WHO pneumonia with severe hypoxemia and without a co-morbidity. The investigators hypothesize that bCPAP will reduce the mortality of Malawian children with WHO-defined severe pneumonia.

NCT ID: NCT02262429 Terminated - Malnutrition Clinical Trials

Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients

Start date: October 2014
Phase: N/A
Study type: Observational

Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.

NCT ID: NCT02077907 Terminated - Clinical trials for Moderate Acute Malnutrition (MAM)

Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial

Start date: January 2014
Phase: N/A
Study type: Interventional

The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Study participants will receive one of four test foods varying in energy and nutrient density as well as amounts provided. 1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group) 2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g sugar, per day 3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day 4. Plumpy'Sup - 500 kcal/d, 92 g/d This will be a prospective, randomised, controlled effectiveness trial. Aims 1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. 2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution 3. (Process) To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, water contamination, hygiene and health behaviors, SES, food security, perceived barriers Outcomes 1. Recovery from MAM 1. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once) 2. Percent default/non-response: children who do not recover after 12 weeks 3. Percent relapse: children who become MAM again within 6 months of recovery 2. Mean number of weeks to recovery Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus. Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have different recovery outcomes to those children fed Super Cereal Plus.

NCT ID: NCT01937884 Terminated - Malnutrition Clinical Trials

Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

SuPPeR
Start date: August 2013
Phase: Phase 2
Study type: Interventional

Optimal delivery of nutritional support during critical illness is central to appropriate intensive care unit management, and yet fundamental gaps in knowledge exist regarding timing, route, dose, and type of nutritional support for critically ill infants and children. Understanding how to optimize nutritional support during pediatric critical illness is important because even brief periods of malnutrition in infancy result in permanent negative effects on long-term neurocognitive development. Optimized nutrition support is a way to improve morbidity for survivors of pediatric critical illness. Parenteral nutrition (PN) supplementation could improve long-term neurocognitive outcome for pediatric critical illness by preventing acute malnutrition, but has unknown effects on intestinal barrier function; a proposed mechanism for late sepsis and infectious complications during critical illness. While randomized controlled trials (RCT) support early PN in premature infants and late PN in critically ill adults, the optimal time to begin PN is unknown for critically ill infants and children. Acute malnutrition may develop within 48 hours of admission in critically ill infants and children, and repleted energy stores are predictive of survival. And yet, due to concerns for PN-associated infectious morbidity, current PICU standard of care is to supplement with PN only in children who fail to enterally feed, as late as 7 days into their admission. Delays in nutrition may have long-term effects on cognitive outcome in older infants and children. In premature infants, PN begun within hours of birth results in improved 18-month neurocognitive outcome without an increase in infectious complications. An RCT is needed to determine if early PN in critically ill infants and children prevents acute malnutrition and improves short and long-term outcomes of PICU hospitalization. The central hypothesis of this proposal is that optimized early protein and calorie delivery will improve nutritional outcomes and intestinal barrier function for critically ill infants and children. The overall purpose of this study is to evaluate the efficacy and safety of early PN as a supplement to enteral nutrition to improve nutritional delivery, nutritional outcomes, and intestinal barrier function for infants and children with acute respiratory failure who are mechanically ventilated in the pediatric intensive care unit.

NCT ID: NCT01810263 Terminated - Stroke Clinical Trials

The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Start date: May 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

NCT ID: NCT01679535 Terminated - Clinical trials for Child Nutrition Disorders

A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

Start date: November 2011
Phase: N/A
Study type: Interventional

This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.

NCT ID: NCT01472237 Terminated - Heart Failure Clinical Trials

Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

PICNIC
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.

NCT ID: NCT01119040 Terminated - Malnutrition Clinical Trials

Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue"

PEGRescue
Start date: November 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine: 1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube. 2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods. 3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.