Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World
24 de febrero de 2017 actualizado por: Duke University
The purpose of this study is to evaluate the accuracy of a new device that may be used for the evaluation and management of malnourished infants and children.
The device will measure the levels of two hormones made by fat tissue: leptin and adiponectin.
Descripción general del estudio
Estado
Terminado
Descripción detallada
The purpose of this study is to validate novel screening tools for the evaluation and management of malnourished infants and children in the developing world.
The study will validate 2-D diffusion point of care testing (POCT) for the rapid analysis of leptin and adiponectin, as these cytokines have been shown to predict mortality in malnourished infants and children.
The study will enroll 20 participants, 10 overweight or obese adolescents presenting to the Duke Division of Pediatric Endocrinology outpatient clinics, in whom leptin is expected to be high and adiponectin low, and 10 premature or small for gestational age infants hospitalized in the Duke Transitional Care Nursery, in whom leptin is expected to be low and adiponectin high.
Informed consent will be obtained and 0-1 mL of blood will be collected and analyzed using the 2-D POCT and commercial ELISA assays.
To reduce potential risks associated with venipuncture and/or finger or heelstick, blood draws for the purposes of this study will take place only when blood sampling is performed at the request of the primary provider, and an attempt will be made to utilize scavenge samples from infants where applicable.
The POCT will be validated against the commercial ELISA assays.
The investigators will analyze the results of each assay in addition to the means and standard deviations of the POCT and ELISAs and will consider the POCT valid if their variation from ELISA is <20%.
The long-term goal of this project is to utilize this novel technology to identify and treat high-risk malnourished infants and children before they have reached the stage of critical, life-threatening illness.
Tipo de estudio
De observación
Inscripción (Actual)
11
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 hora a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The investigators plan to recruit 10 overweight or obese adolescents followed by the Duke Division of Pediatric Endocrinology and Diabetes. Investigators will review the electronic medical records of potential participants identified by their primary providers to ensure they meet the eligibility criteria.
The investigators will also recruit 10 infants hospitalized in the Duke Transitional Care Nursery and will review the electronic medical records of potential participants identified by their primary providers to ensure they meet the eligibility criteria.
Descripción
Inclusion Criteria:
Overweight or Obese: Inclusion criteria for these subjects will include:
- Age 8-17 years;
- male or female; and
- BMI >85% for age.
Premature or Small for Gestational Age: Inclusion criteria for these subjects will include:
- Age <1 year,
- male or female,
- small for gestational age or intra-uterine growth restriction (IUGR) defined by the 9th revision of the International Classification for Diseases OR
- prematurity as defined by the 9th revision of the International Classification for Diseases.
Exclusion Criteria:
- Exclusion criteria include refusal or inability to provide samples of blood.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Overweight or Obese
Children being seen in consultation or follow-up within the Duke Division of Pediatric Endocrinology and Diabetes who are overweight or obese.
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Premature or Small for Gestational Age
Infants hospitalized in the Duke Transitional Care Nursery who were born prematurely or small for gestational age.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Variation between results of novel screening tool and standard ELISA
Periodo de tiempo: 1 year
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The 2-D diffusion POCT will be validated against commercial ELISA assays, run in the Duke Molecular Physiology Institute laboratory, using recombinant human leptin and high molecular weight adiponectin from blood samples.
Dose-response curves will be generated using analyte-spiked buffer.
The dose-response data from 20 separate dose-response dilutions will be fit with the five-parameter logistic (5-PL) curve.
The coefficients of variation (inter and intra-assay) for standard ELISAs for leptin and adiponectin assays are less than 10%.
The investigators will analyze the results of each assay in addition to the means and standard deviations of the POCT assays and ELISAs.
The POCT assay will be considered valid if the variation from the ELISA is less than 20% and if there is no statistically significant difference between the means and standard deviations.
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1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2015
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de mayo de 2016
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2015
Publicado por primera vez (Estimar)
20 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
24 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00058058
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .