Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Overweight or Obese: Inclusion criteria for these subjects will include: 1. Age 8-17 years; 2. male or female; and 3. BMI >85% for age. - Premature or Small for Gestational Age: Inclusion criteria for these subjects will include: 1. Age <1 year, 2. male or female, 3. small for gestational age or intra-uterine growth restriction (IUGR) defined by the 9th revision of the International Classification for Diseases OR 4. 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.


NCT ID:

NCT02449408


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.