Comprehensive online monitoring of early developmental trajectories of infants/toddlers with orofacial clefts - orofacial clefts are the most common congenital malformations, with cleft LIP and/or…

The National Institute of Dental and Craniofacial Research awarded the Regents of the University of Michigan $710,519 on August 1, 2026, under the Oral Diseases and Disorders Research program (CFDA 93.121) to establish a comprehensive, web-based developmental monitoring system for infants and toddlers with orofacial clefts.

The project will track developmental status and trajectories across multiple domains—social/communication/cognition skills, motor abilities, early relational health, sleep, and feeding/elimination—in a large, multi-site cohort with nonsyndromic cleft lip and/or cleft palate using the empirically validated PEDIATRAC methodology. PEDIATRAC is a low-cost, caregiver-based online assessment tool that gathers longitudinal data across the first 18 months of life and measures growth trajectories to detect deviations more sensitively than cross-sectional assessments. The project will identify infants and toddlers at risk for neurodevelopmental deviations and establish a monitoring system to enhance early identification and guide early intervention referrals, addressing the current gap in clinical guidelines for comprehensive serial developmental assessments and tracking of surgical intervention effects in this population.

Performance takes place in Ann Arbor, Michigan, with a period of performance from August 1, 2026, through July 31, 2031.

Comprehensive online monitoring of early developmental trajectories of infants/toddlers with orofacial clefts - orofacial clefts are the most common congenital malformations, with cleft LIP and/or cleft palate (CLP) occurring in 1 in 700 births globally. Although there are significant developmental risks, current treatment guidelines do not address the need for comprehensive serial developmental assessments through infancy/toddlerhood. Additionally, there are no clinical guidelines for tracking the early developmental effects of surgical interventions. Clearly, there is a critical need to provide empirically validated comprehensive developmental monitoring to identify needs for early intervention. At this point, monitoring largely depends on burdensome follow-up at specialty clinics with restricted access and a limited number of clinicians with specific expertise. Developmental screeners based on caregiver report can be completed from home; however, there are many psychometric and content limitations to the currently available instruments. The empirically validated pediatrac methodology using caregiver-based assessment is ideally suited for these purposes. Pediatrac is a low cost and web-based method for gathering longitudinal, multi-domain data on development across the first 18 months of life. IT measures core developmental domains (social/communication/cognition skills, motor abilities, early relational health, sleep, feeding/elimination), and provides growth trajectories which have been shown to be more sensitive to the detection of deviations than currently utilized cross-sectional assessments. The overall objective of the proposed project is to track infant/toddler developmental status and trajectories in a large, multi-site cohort with nonsyndromic CLP and identify those at risk for neurodevelopmental deviations. The long-term objective is to establish a comprehensive, efficient, caregiver-report monitoring system to enhance early identification of developmental deviations and needs in infants/toddlers with CLP. Caregiver-infant dyads will be followed beginning in the newborn period and at 2, 4, 6, 9, 12, 15, and 18 months of age. Data on medical, demographic, and family risk factors will also be collected to examine predictors of development. At 24 months, the bayley-4 will be administered to a subset of toddlers to examine the predictive value of caregiver ratings, using a direct measure of developmental outcome. The project objective will be achieved through the following aims: aim 1. We will track the early developmental status and trajectories of infants/toddlers with CLP compared with a nonclp matched comparison group obtained from our previous studies of term and preterm infants; aim 2. We will examine infant motor and social/communication/cognition developmental trajectories based on parent report as predictors of developmental status at 24 months of age in children with CLP; aim 3. We will examine the effects of medical/surgical factors on infant/toddler development and 24-month outcomes. Our expected outcome is an accessible, efficient, and compelling improvement in developmental monitoring and early identification that ensures earlier access to care for this population.