Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World

Overweight, Obesity, Small for Gestational Age, Prematurity Clinical Trial

Official title:

Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449408
• Other study ID #: Pro00058058
• Status: Completed
• Phase: N/A
• First received: May 18, 2015
• Last updated: February 24, 2017
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Overweight
• Overweight, Obesity, Small for Gestational Age, Prematurity

Intervention

Other:
• Measurement of leptin and adiponectin obtained through blood sampling via venipuncture or finger/heelstick using novel screening tool

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation between results of novel screening tool and standard ELISA	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.	1 year