A Study for Toddlers 22 to 26 Months Old Who Were Prenatally Diagnosed with a Rare Condition

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate the neurologic (nervous system), behavioral and developmental progress of children who are 22 to 26 months old and were prenatally diagnosed with a rare condition.

Who can participate?

Children 22 to 26 months old who were prenatally diagnosed with a rare condition, including amniotic band syndrome, bladder outlet obstruction, congenital lung lesions, fetal tumors, spina bifida, twin-to-twin transfusion, or those that have received a fetal surgery among others, may be eligible to participate.

Conditions

  • Disabilities - Developmental
  • Disabilities - Physical
  • Genetics - Chromosome Abnormalities
  • Spina Bifida
  • Urology - Kidney - Bladder
  • Chest and Lungs - Respiratory Tract

What will happen in the study?

Your child will participate in behavioral and developmental testing, which will last 1 ½ to 2 hours per child. All evaluations are performed in a clinical setting and are not invasive. We will look at and record the data in your child’s chart for research purposes, including information about their health, growth and development.

We will also collect test results from before and after your child was treated including laboratory, heart test and lung function results. We will keep this information for a period of time in a data base, to use as data for future studies. Your child’s information would have a unique study ID number, so that his/her name will not appear on any data sheets or questionnaires.

Parents or guardians interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your child will not receive a direct medical benefit from participating in this study. However, the information learned from this study may help other patients prenatally diagnosed with a rare condition in the future.

What are the bad things that can happen from this research?

Possible risks will be discussed with parents or guardians interested in learning more about the study.

Will you/your child be paid to be in this research study?

Families will receive between $25 and $100 for this 1 study visit, depending upon travel time.

Contact

Contact Us.Trish Burns
513-803-5270
trish.burns@cchmc.org
Cincinnati Fetal Center
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Foong-Yen Lim, MD
Division of Pediatric General and Thoracic Surgery
Cincinnati Children’s Hospital Medical Center