NCT03107520 Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
| NCT ID | NCT03107520 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Developmental Dysplasia of the Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2017-05-22 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 125 participants in total. It began in 2017-05-22 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * \> 24 months of age at the time of surgery. * 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.
Contact & Investigator
Wudbhav N Sankar, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT03107520 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 24 Months, studying Developmental Dysplasia of the Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03107520 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03107520 currently recruiting?
Yes, NCT03107520 is actively recruiting participants. Contact the research team at sankarw@chop.edu for enrollment information.
Where is the NCT03107520 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT03107520 clinical trial?
NCT03107520 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Wudbhav N Sankar, MD at Children's Hospital of Philadelphia. The trial plans to enroll 125 participants.