Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World
Condition: Overweight, Obesity, Small for Gestational Age, Prematurity
MeSH terms: Overweight
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Measurement of leptin and adiponectin obtained through blood sampling via venipuncture or finger/heelstick using novel screening tool
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.