Status:
COMPLETED
Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly
Lead Sponsor:
Meyer Children's Hospital IRCCS
Collaborating Sponsors:
Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Plagiocephaly, Positional
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Positional occipital plagiocephaly (POP) is a morphological abnormality of the cranium which, in the absence of early synostosis of the cranial sutures, is caused by external forces acting on the skul...
Eligibility Criteria
Inclusion
- Participation of parents in the prenatal course at 34-38 weeks of gestation;
- Signing of the informed consent form;
Exclusion
- parents (mother or both) aged \< 18 years;
- foreign parents with difficulty in understanding the Italian language and therefore giving informed consent to the study.
- In addition, children who present the following conditions at birth has been excluded from the study:
- prematurity with gestational age \< 36 weeks;
- neonatal distress;
- congenital occipital plagiocephaly - with cranial asymmetry measurable using a craniometer and ODDI (cranial asymmetry index) \> 112.6%;
- clavicle fractures;
- congenital clubfoot, metatarsus varus;
- congenital spinal and pelvic abnormalities.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07182604
Start Date
January 1 2023
End Date
April 30 2024
Last Update
September 19 2025
Active Locations (1)
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1
Viola Fortini
Florence, FI, Italy, 50139