Clinical Trials Office

Study for Children/ Teens Who Need Total Parenteral Nutrition

What is the purpose of this study?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to determine if infants, children and teenagers who need TPN because of their inability to absorb sufficient nutrients have lower bone mineral density than healthy children.

Who can participate?

Infants, children and teenagers 6 months to 17 years old in need of TPN to support their nutrition may be eligible to participate.

Ages

  • From 6 To 12  months old
  • From 1 To 17  years old

Conditions

  • Weight/Nutrition

What is involved?

The study involves 1 or 2 study visits. The following outlines some of the procedures included in this study:

Your child will have:

    • His/her medical record reviewed 
    • His/her information collected such as weight, height, birth date, etc.
    • A special X-ray study of the bone
    • A tibial (lower leg) ultrasound, a painless procedure that uses ultrasound waves to take measurements to determine bone strength
    • Blood draws to help measure bone health, growth factors, etc.

You will:

    • Be asked to accompany your child to all study visits 
    • Be asked about your child’s medications, birth weight, diet, including TPN and formula, other medical conditions, etc.

What are the benefits?

Your child will not receive a direct benefit from participating in this research study. The information learned from this study may benefit other patients who are TPN dependent in the future.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form.

Do participants receive pay, compensation or reimbursement?

Families will receive a $25 gift card for time and travel.

Who should I contact for more information?

Donna Buckley
513-636-8549
513-736-1300 (Pager)
Cincinnati Children’s Hospital Medical Center

Principal Investigator

Stephanie Appleman, MD
Gastroenterology, Hepatology, & Nutrition
Cincinnati Children’s Hospital Medical Center

Date

Ongoing