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NewbornNCT03109444

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

An observational study of Newborn and Hip Dysplasia, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 6 weeks
Conditions the study is for
Newborn, Hip Dysplasia
What is being tested?
Hip Ultrasound
How many people
75 participants
Where
1 siteUnited States
Study dates
25 Oct 2017to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 weeks
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Community Regional Medical Center

    Fresno, California, 93721

Other trials in United States

About this study

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.

Read the detailed description

This is a prospective population cohort study of newborns that are born at Community Regional Medical Center (CRMC). Legally authorized representatives (LAR) of the newborn will be approached by research staff after the birth of their baby, informed about the study and then asked if they would like to participate. Due to the high volume of births at CRMC, LARs will be approached approximately once a week for a convenience sample.

If a LAR is interested in participating, they will be consented to be in the study.

After a LAR consents for participation 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.

Study Follow-Up LARs and 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. Normal infant hip ultrasound maturity is defined as an alpha angle of > 60 degrees (this is the angle between the roof of the acetabulum and the lateral iliac wing and indicates morphology of the acetabulum) and a percent coverage of the femoral head in the acetabulum of > 50%. A Board Certified Pediatric Radiologist, a Board Certified Pediatric Orthopaedic Surgeon and an Orthopaedic Resident will interpret each study. If there is less than 5 degree or 5 percent difference between the interpretations the mean will be used as the reading. If there is a greater difference, the case will be reviewed for consensus. Corrected age is defined as actual age in weeks minus weeks premature. For example, a newborn born at 32 weeks gestational age (8 weeks premature) would be followed for 14 weeks total (14 weeks actual age-8 weeks premature=6 weeks adjusted age).

If a newborns hips reach the criteria for newborn hips before they reach 6 weeks adjusted age, they will discharged from the study as they have reached the standard for infant hip maturity (this could happen at their initial scan or any time after). LAR and newborns will return to CRMC Radiology Department to get the follow up ultrasounds therefore there will be an incentive of $15 a follow up visit. Incentive will not be provided for studies performed while a hospital inpatient. If a patient shows persistent radiographic signs of dysplasia at any point while they are in the study, they will exit the study protocol and receive standard treatment for hip dysplasia as medically indicated.

Basic demographics initially (gender, race/ethnicity, age of the mother), birth presentation (normal or breach), multiple birth, the number of births that the mother has had, family history of hip dysplasia, gestational age, alpha angle and percent coverage as defined above (measured by three independent observers) will be collected at the initial exam. At each follow up exam the following data will be collected; date of exam, gestational age, corrected age, alpha angle, percent coverage and any notes about the exam. In addition, contact information will be collected so that follow up visits can be scheduled. All data will be entered into REDCap, UCSF's HIPAA compliant data entry site.

Being tested
Hip Ultrasound
Keywords
Hip Growth Chart
Medical subject headings
Hip Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hip UltrasoundDiagnostic 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%.

Study groups in NCT03109444
Study groupRoleWhat they receive
Hip Ultrasound of Newborn infantsNewborns 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.
Receives: Diagnostic Test: Hip Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alpha Angle in degrees

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

    Measured: Measured weekly from birth to 6 weeks corrected age

  2. Percent Coverage

    Percent coverage of the femoral head in the acetabulum

    Measured: Measured weekly from birth to 6 weeks corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start25 Oct 2017
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03109444
Sponsor's protocol ID
Hip Growth Chart
Status last verified
Jul 2026
First submitted
6 Apr 2017
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Newborn and Hip Dysplasia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alpha Angle in degrees (time frame: Measured weekly from birth to 6 weeks corrected age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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