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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:11/14/2018
Start Date:October 25, 2017
End Date:December 31, 2019
Contact:Lisa Husak, MPH
Email:lhusak@fresno.ucsf.edu
Phone:559-459-4372

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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.

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.

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.
We found this trial at
1
site
Fresno, California 93721
Principal Investigator: John Wiemann, MD
Phone: 559-459-4372
?
mi
from
Fresno, CA
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