Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

NCT06474741 | Not Yet Recruiting

• 1 other identifier: CStatenIslandCUNY
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question\[s\] it aims to answer are:

• whether an app can successfully deliver an intervention to parents of young infants
• whether parents who learn about torticollis will increase behaviors intended to prevent torticollis compared to parents who learn about general infant development Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.

Conditions

Torticollis

Keywords

prevention

Outcome Measures

Primary Outcomes (1)

• symmetry score

  extent of infant's head turn asymmetry

  baseline and 4 months

Secondary Outcomes (5)

• gaze asymmetry score

  6 months

• time spent in focused attention

  6 months

• # of bouts of focused attention

  6 months

• correlation between computer vision algorithm & manual coding for infants' head turns

  4 months

• Correlate computer vision score with clinical test of symmetry

  4 months

Study Arms (2)

intervention

EXPERIMENTAL

in-app twice-weekly parent notification about torticollis and head turn asymmetries

Behavioral: in-app notification

control

NO INTERVENTION

in-app twice-weekly parent notification about general infant development

Interventions

in-app notification BEHAVIORAL

Parents will receive bi-weekly prompts in a baby monitor app to change infant's orientation within crib, allow for tummy time several times per day, alternate the side from which infants are fed, alternate the side the infant faces during carrying, and in general note any side preferences of the infant so that positioning can assist in symmetry.

intervention

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• any parent with an infant under a month old who can answer a survey in English

You may not qualify if:

• infant already has a diagnosis of torticollis or plagiocephaly

Sponsors & Collaborators

• College of Staten Island, the City University of New York: lead
• Duquesne University: collaborator

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06