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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    75
  • sponsor
    University of California, San Francisco
Updated on 27 March 2021
hip dysplasia
hip ultrasound

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.

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.

Details
Condition Neonate, Hip Dysplasia, congenital hip dysplasia, newborn
Treatment Hip Ultrasound
Clinical Study IdentifierNCT03109444
SponsorUniversity of California, San Francisco
Last Modified on27 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note