NCT06901414

Brief Summary

This retrospective register-based cohort study investigates the association between birth complications, intrauterine crowding, and the development of congenital muscular torticollis (CMT). CMT is characterized by the shortening and tightening of the sternocleidomastoid muscle, leading to abnormal head positioning. The study will analyze data from the Norwegian Medical Birth Registry (MFR) and the Norwegian Patient Registry (NPR) to determine whether individuals with CMT have a higher prevalence of birth complications or signs of intrauterine crowding compared to the general population. By identifying risk factors associated with CMT, this study aims to identify the possible etiology of CMT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,105

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

March 22, 2025

Last Update Submit

March 28, 2025

Conditions

Keywords

Congenital muscular torticollisBirth traumacrowdingetiologybirth registry

Outcome Measures

Primary Outcomes (1)

  • Use of vacuum, forceps extraction

    The use of vacuum extraction or forceps (operative deliveries), indicates birth complications. It has been hypothesized that such operative deliveries are associated with an increased incidence of congenital muscular torticollis. These variables are consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Data from the time period of 1990 to 2023.

Secondary Outcomes (7)

  • Caesarean section

    1990-2023

  • Breech position

    1990-2023

  • Clavicle fracture

    1990-2023

  • Macrosomic infants

    1990-2023

  • Multiple gestations

    1990-2023

  • +2 more secondary outcomes

Study Arms (2)

CMT cases

Children identified in the Norwegian Patient Registry (NPR) with the diagnosis of congenital muscular torticollis (ICD-10 Q68.0) born between 1990 and 2023

Matched control group

Consisting of individuals from the general population, matched in a 1:4 ratio based on birth year, sex, and gestational age at birth.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include a cohort of individuals diagnosed with congenital muscular torticollis (CMT) who have been diagnosed and/or undergone surgical treatment in Norway during the time period of 1990 to 2023. These cases will be identified from the Norwegian Patient Registry (NPR) based on diagnosis and procedure codes. The control group will consist of individuals from the general population, matched in a 1:4 ratio based on birth year, sex, and gestational age at birth. The study will analyze perinatal and birth-related factors, such as mode of delivery, signs of birth trauma, and intrauterine conditions, using data from the Norwegian Medical Birth Registry (MFR).

You may qualify if:

  • Individuals diagnosed with congenital muscular torticollis (ICD-10 code: Q68.0) and registered in the Norwegian Patient Registry (NPR).
  • Born in Norway after 1990
  • Underwent surgical treatment for CMT (procedure codes NAL39/NAL69/NAL99).

You may not qualify if:

  • Individuals with incomplete birth registry data in the MFR.
  • Presence of congenital anomalies unrelated to CMT that could confound study outcomes.
  • Cases with missing gestational age, birth weight, or delivery method.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken HF

Drammen, 3004, Norway

Location

MeSH Terms

Conditions

Congenital torticollisBirth InjuriesCrowding

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesSpatial BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2025

First Posted

March 28, 2025

Study Start

November 26, 2024

Primary Completion

November 26, 2024

Study Completion

November 26, 2024

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Despite the fact that our data are non-identifiable, the permission granted us by the Regional Ethics Committee does not allow us to share data outside our study group.

Locations