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.
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.
- 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
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
- Exclusion criteria include refusal or inability to provide samples of blood.