Infant Head Measurement Study

Comparing Infants’ Digital Cranial Evaluation and Manual Measurements

Protocol Description

This study compares standard-of-care manual infant head shape measurements with those collected via a novel digital cranial evaluation app. Researchers want to determine whether digital cranial evaluations can determine cranial index, cranial vault asymmetry index, and head circumference to diagnose plagiocephaly or flat head syndrome with a high correlation to manual measurements by specialists. The overarching goal is to create a means of early identification of head deformity in infants to help mitigate the need for costly therapies.

Eligibility Criteria

Infants up to 12 months of age who are being seen by members of the study team in the Deformational Plagiocephaly and Torticollis Clinic at UPMC Children’s Hospital of Pittsburgh are eligible for enrollment.
Male and Female Infants: Up to 12 months of age

Requirements

Participation consists a researcher taking digital photos of the top of the infant’s head using a cranial measurement app and collecting head circumference and other measurements through traditional means, as well as medical history and other relevant information. De-identified photos and medical information will be provided to the study sponsor for evaluation to determine the correlation between manual measurements with those done using the digital cranial evaluation app.
Visits: 1; However, if the child is subsequently seen by the Plastic Surgery Division for additional care, follow-up measurements and photos will be repeated.
Duration: Not applicable

Status: Enrolling by Invitation

Source(s) of Support

PediaMetrix

Primary Investigator

Regina Fenton, CRNP

Contact Information

For more information about the study, please contact:
Research Specialist Jennifer Fantuzzo, BS
412-692-7949