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Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
RecruitingEarly phase 1
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
Who can join
4 Months – 24 Months · All sexes
Full 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.
About the study
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.
What is being tested
- Intraoperative contrast-enhanced ultrasound (CEUS) (diagnostic test)
- Lumason (drug)
Sponsor: Children's Hospital of Philadelphia · Participants: 125 · Started: May 22, 2017
Contact the study team
- Wudbhav N Sankar, MD · Phone: 215-590-1527
- Susan Back, MD · Phone: 215-590-7000
Official record on ClinicalTrials.gov — NCT03107520
Locations in the U.S.
| Pennsylvania | The Children's Hospital of Philadelphia, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.