Frontlight ResearchEarly access
Taking people in United StatesEarly phase 1
Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
Key facts
- Who runs it
- Children's Hospital of Philadelphia
- Where
- Philadelphia, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 125 people, planned
- Started
- 22 May 2017
- Expected to end
- Apr 2030
- Type of study
- Interventional
- Treatments tested
- Intraoperative contrast-enhanced ultrasound (CEUS)
- Lumason
- Record updated
- 15 April 2026
Who can take part
- Age
- 4 months to 24 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Males or females between 4 months and up to and including 24 months of age at the time of surgery
- Diagnosed with DDH
- Failed conservative treatment, or present with late-diagnosed DDH (where conservative treatment would not be appropriate to initiate at their age), and are undergoing closed or open reduction and spica casting
- Informed consent (parental permission)
Who cannot take part
- Subjects with DDH who are successfully treated with conservative measures and do not require surgical reduction
- Previous open hip reduction of the affected side
- Children with known complex congenital heart disease or unstable cardiopulmonary conditions (as noted in the package labeling for Lumason) including acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure or serious ventricular arrhythmias will be excluded
- History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Ns), palmitic acid).Parental/guardian permission (informed consent) and if appropriate, child assent
- > 24 months of age at the time of surgery
Where in United States
- The Children's Hospital Of PhiladelphiaPhiladelphia, United StatesContact: Wudbhav N. Sankar, MDTaking people
About the trial
What the trial wants to find out
This study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide real-time assessment of blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip.
The group in the trial
- DDH Surgical Reduction PatientsTreatment being tested
Infants treated for DDH who failed conservative measures and are undergoing intraoperative open or closed hip reduction. Intraoperative contrast-enhanced ultrasound using Lumason contrast agent will be administered to improve visualization of the epiphyseal vascularity after hip reduction and during placement of the spica cast.
Treatment: Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Use of Intraoperative Contrast-enhanced Ultrasound to Evaluate Femoral Head Perfusion in Infants With Developmental Dysplasia of the Hip at the Time of Surgical Reduction
- Record updated
- 15 April 2026