Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03107520
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
24 Months
Study:
NCT03107520
Study Brief:
Protocol Section:
NCT03107520