Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

NCT ID: NCT06474741

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Torticollis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

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

Group Type EXPERIMENTAL

in-app notification

Intervention Type 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.

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

in-app notification

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* infant already has a diagnosis of torticollis or plagiocephaly
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duquesne University

OTHER

Sponsor Role collaborator

College of Staten Island, the City University of New York

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CStatenIslandCUNY

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Newborn Head Molding and Later Asymmetries
NCT02283229 ENROLLING_BY_INVITATION NA