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Not yet recruitingNCT06474741Updated Jun 26, 2024

Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

An interventional study of in-app notification in Torticollis, sponsored by College of Staten Island, the City University of New York. Not yet recruiting. Open to participants aged 1 Day to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by College of Staten Island, the City University of New York · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
1 Day to 1 Month
Sex
All
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Study 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.

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Conditions studied

  • Torticollis

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Keywords

  • prevention
03

In context

Torticollis

121 studies on the registry are indexed under Torticollis; 18 are open to participants now.

This study's planned enrollment of 56 is above the median of 50 across 76 interventional studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

College of Staten Island, the City University of New York is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 1 Month
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • infant already has a diagnosis of torticollis or plagiocephaly
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    intervention

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

    Behavioral: in-app notification

  • No intervention
    control

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

Interventions

  • Behavioralin-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.

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What researchers measure

Primary outcomes

  1. symmetry score

    extent of infant's head turn asymmetry

    Time frame: baseline and 4 months

Secondary outcomes

  1. gaze asymmetry score

    extent of infant's eye gaze asymmetry

    Time frame: 6 months

  2. time spent in focused attention

    Time frame: 6 months

  3. # of bouts of focused attention

    Time frame: 6 months

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

    Time frame: 4 months

  5. Correlate computer vision score with clinical test of symmetry

    Time frame: 4 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — Individual participant data that underlie results reported in published articles, after deidentification, as well as the study protocol, statistical analysis plan, and informed consent form, will be available beginning 9 months and ending 5 years following publication. Only investigators whose proposed use of the data has been approved by a learned intermediary shall have access to conduct analyses as approved in the proposal.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06474741
Lead sponsor
College of Staten Island, the City University of New York
Collaborators
Duquesne University
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 2025 (estimated)
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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