Normative Radiographic Parameters and Growth Curve of Hips Less Than Six Weeks of Gestational Age Using Ultrasound

NCT03109444 | Unknown

• 1 other identifier: Hip Growth Chart
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to collect normative population data on the ultrasound radiographic parameters used to evaluate hip dysplasia in infants between 32 and 46 weeks of gestational age. This data would be utilized to develop a growth chart with standard deviations for this cohort that would be beneficial in the appropriate treatment of suspected hip dysplasia.

Conditions

Newborn; Hip Dysplasia

Keywords

Hip Growth Chart

Outcome Measures

Primary Outcomes (2)

• Alpha Angle in degrees

  The angle between the roof of the acetabulum and the lateral iliac wing and indicates,morphology of the acetabulum.

  Measured weekly from birth to 6 weeks corrected age

• Percent Coverage

  Percent coverage of the femoral head in the acetabulum

  Measured weekly from birth to 6 weeks corrected age

Study Arms (1)

Hip Ultrasound of Newborn infants

Newborns born at CRMC (term newborns and pre-mature newborns over 32 weeks gestational age). This will include newborns cared for in the neonatal intensive care unit (NICU) over 32 weeks gestational age, and newborns cared for on the normal labor and delivery floor. the newborn will receive an ultrasound of their hips while in the hospital (done by a trained sonographer). This will happen in the patient's room with the LAR present. An ultrasound of the hip takes approximately 15 minutes and is non-invasive, non-painful and does not utilize any ionizing radiation. Newborns will be scheduled to return once a week until the newborn's hips reach criteria for normal hip morphology or the newborn reaches 6 weeks of corrected age.

Diagnostic Test: Hip Ultrasound

Interventions

Hip Ultrasound DIAGNOSTIC_TEST

Both hips will be examined. The diagnostic examination for developmental dysplasia of the hip (DDH) incorporates 2 orthogonal planes: a coronal view in the standard plane at rest and a transverse view of the flexed hip at rest. It is acceptable to perform the examination with the infant in a supine or a lateral decubitus position. The anatomic coronal plane is approximately parallel to the posterior skin surface of an infant. The imaging plane is through the deepest part of the acetabulum (which includes visualization of the triradiate cartilage and the ischium posteriorly), the resulting image will be a coronal view in the standard plane. The standard plane is defined by identifying a straight iliac line, the tip of the acetabular labrum, and the transition from the os ilium to the triradiate cartilage. Acetabular morphology is assessed in this view and may be validated by measuring the acetabular alpha angle (≥60°). The femoral head coverage by the bony acetabulum should be \>50%.

Hip Ultrasound of Newborn infants

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Convenience sample of of newborns that are born at Community Regional Medical Center (CRMC).

You may qualify if:

• newborns born at CRMC (term newborns and pre-mature newborns over 32 weeks gestational age.
• newborns in NICU
• newborns on postpartum floor
• single birth
• multiple births
• normal presentation
• breach presentation

You may not qualify if:

• known neuromuscular or genetic condition predisposing infant to hip dysplasia (i.e. Spina Bifida, Cerebral Palsy),
• inability to follow up (i.e. doesn't live in surrounding area),
• frankly dislocated hips that require immediate treatment,
• any medical condition precluding safe hip ultrasound.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• John Wiemann, MD

  UCSF - Fresno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Lee, MPH

CONTACT

559-459-4372; Jlee@fresno.ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: October 25, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)