Clinical trial NCT02449408: Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World
Official title: Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight, Obesity, Small for Gestational Age, Prematurity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Variation between results of novel screening tool and standard ELISA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: