Brain Development and Pre-Speech Function in Infants with Isolated Oral Clefts - Isolated cleft of the lip and/or palate

STUDY BASICS

Are you the parent/guardian of a two month-old infant with or without an isolated cleft lip/palate? You and the infant may be able to participate in a research study to understand the impact of exposure to anesthesia and oxygen levels on development. Compensation is provided.

STUDY PURPOSE

We are inviting your child to participate in this research study because your child is either an infant with an isolated cleft of the lip and/or palate (iCL/P; case group) or an infant unaffected by an oral cleft or other developmental disorders (control group). 

The purpose of this research study is to evaluate any potential impact that exposure to anesthesia and reduced oxygenation (i.e., when less oxygen is brought to the blood due to breathing issues) has on brain development and functioning in the first year of life. Children with iCL/P are at an increased risk for later speech/language deficits, but very little is known about the impact early surgeries and obstructed airways may have on the development of these skills. 

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

Eligible participants are:

• Parents/guardians with a 2-month old infant
• Infants with or without a cleft lip or palate

WHAT PARTICIPANTS CAN EXPECT

This study will involve two visits (when your child is 2 months and 6-8 months old). The first visit will take place at UPMC Children's Hospital of Pittsburgh. It is preferred for the second visit to also take place at UPMC Children's Hospital of Pittsburgh, but procedures can take place in the home in special cases. Each visit will include:

• Parent/Guardian Questionnaires
• Brain Imaging 
• Vocal Recording 
• Oxygenation Monitoring (this part will take place in your home)
• Medical Chart Review