Sound Conduction of Infant Hips
Primary Purpose
Developmental Dysplasia of the Hip
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustical Resonance Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Developmental Dysplasia of the Hip
Eligibility Criteria
Inclusion Criteria:
- Infants included in this study must be born at full term with a gestational age of 0-6 months
- Infants of both genders will be included
- Infants must have been screened for DDH.
Exclusion Criteria:
- Infants born prematurely
- Infants greater than six months of age.
- Nonviable neonates and neonates of uncertain viability
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Infants with developmental dysplasia of the hip
Infants without developmental dysplasia of the hip
Arm Description
Infant participants putting on a device for 15 minutes to take different measurements of the hip
Infant participants putting on a device for 15 minutes to take different measurements of the hip
Outcomes
Primary Outcome Measures
Difference in soundwaves on the Actuator on patella, sensor on sacrum
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Secondary Outcome Measures
Full Information
NCT ID
NCT05188235
First Posted
December 20, 2021
Last Updated
February 7, 2023
Sponsor
NYU Langone Health
Collaborators
University of Central Florida
1. Study Identification
Unique Protocol Identification Number
NCT05188235
Brief Title
Sound Conduction of Infant Hips
Official Title
Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
University of Central Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).
Detailed Description
This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH.
For both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dysplasia of the Hip
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infants with developmental dysplasia of the hip
Arm Type
Experimental
Arm Description
Infant participants putting on a device for 15 minutes to take different measurements of the hip
Arm Title
Infants without developmental dysplasia of the hip
Arm Type
Active Comparator
Arm Description
Infant participants putting on a device for 15 minutes to take different measurements of the hip
Intervention Type
Device
Intervention Name(s)
Acoustical Resonance Device
Intervention Description
Infants will be studied for 15 min using an electronic "tuning fork" to transmit sound through the hip from a point on the skin while transmitted sounds FDA-approved stethoscope
Primary Outcome Measure Information:
Title
Difference in soundwaves on the Actuator on patella, sensor on sacrum
Description
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Time Frame
Study visit 1 (Day 1)
Title
Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis
Description
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Time Frame
Study visit 1 (Day 1)
Title
Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum
Description
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Time Frame
Study visit 1 (Day 1)
Title
Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest
Description
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Time Frame
Study visit 1 (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants included in this study must be born at full term with a gestational age of 0-6 months
Infants of both genders will be included
Infants must have been screened for DDH.
Exclusion Criteria:
Infants born prematurely
Infants greater than six months of age.
Nonviable neonates and neonates of uncertain viability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Castaneda, MD
Phone
(212) 598-6624
Email
Pablo.Castaneda@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joie Cooper, MS
Phone
(212) 460-0177
Email
Joie.Cooper@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Castaneda, MD
Organizational Affiliation
NYU Lagone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Castaneda, MD
Phone
212-598-6624
Email
Pablo.Castaneda@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Joie Cooper, MS
Phone
(212) 460-0177
Email
joie.cooper@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Pablo Castaneda, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to study team members. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Sound Conduction of Infant Hips
We'll reach out to this number within 24 hrs