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

February 24, 2017 updated by: Duke University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 hour to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Overweight or Obese
Children being seen in consultation or follow-up within the Duke Division of Pediatric Endocrinology and Diabetes who are overweight or obese.
Other: Measurement of leptin and adiponectin obtained through blood sampling via venipuncture or finger/heelstick using novel screening tool
Premature or Small for Gestational Age
Infants hospitalized in the Duke Transitional Care Nursery who were born prematurely or small for gestational age.
Other: Measurement of leptin and adiponectin obtained through blood sampling via venipuncture or finger/heelstick using novel screening tool

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variation between results of novel screening tool and standard ELISA
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00058058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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