Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
With evidence-based information from MPS registries regarding the types of surgical interventions that are most prevalent in MPS, this screening study is expected to provide the understanding of the role pediatric ENT surgeons can play in identifying young children with MPS.
Age
0–7
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Each subject must meet the following criteria to be enrolled in this study:
1. The subject is male.
2. The subject is \<7 years of age.
3. The subject has had or is scheduled for ENT surgery for any of the following, alone or in combination: adenoidectomy, tonsillectomy, and tympanostomy.
4. The subject has record of previous surgical repair or presence of inguinal and/or umbilical hernia.
5. The subject's parent(s) or the subject's legally authorized representative(s) has provided written informed consent that has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
You may not be if
Subjects who meet any of the following criteria will be excluded from the study:
1. The subject has a current confirmed diagnosis of any MPS disorder.
2. The subject was born prematurely (defined as born before 37 weeks gestation).
3. The subject has received a blood transfusion within the past 6 weeks.
4. The subject has received a bone marrow transplant.
Clareo Health | Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)