Using ultrasound to assess blood flow during hip surgery for infants with hip dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility of using contrast-enhanced ultrasound (CEUS) to assess blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip (DDH). The approach aims to provide real-time insights during surgery, potentially reducing the risk of avascular necrosis, a common complication. By utilizing CEUS, the study seeks to improve surgical outcomes by identifying intraoperative factors that may contribute to blood flow issues. The intervention involves administering Lumason, a contrast agent, during the surgical procedure.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Wudbhav N Sankar, MD — Children's Hospital of Philadelphia
• Study coordinator: Wudbhav N Sankar, MD
• Email: sankarw@chop.edu
• Phone: 215-590-1527

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.