Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT07182604
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly
Sponsor:
Meyer Children's Hospital IRCCS
Organization:
Study Overview
Official Title:
Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly: a Randomized Multicenter Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POP2019
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 skull, which is highly malleable in newborns. The most common form of POP is the "acquired" type, which manifests around 2-3 months of age and reaches its peak severity around 4 months. The incidence of POP is 46.6% at 7-12 weeks of life, and 78.3% of cases are mild severity. In addition to being an aesthetic problem, POP can alter the first phase of a child's postural-motor development, causing postural asymmetries in the neck or spine, or asymmetries in the functional motor skills. Often, attention is only paid to the condition at a later stage, when the situation is very evident and often associated with other issues, resulting in longer, more expensive physiotherapy treatments and poorer outcomes.
Recently, interest has emerged in the possibility of preventing POP: studies have been conducted showing that preventive and educational intervention with families on the most appropriate ways of caring for their babies after birth effectively reduces the incidence and severity of POP in the first months of life and that good nationwide training of healthcare professionals on this topic could help minimize public healthcare costs.
The Specialist Interest Group (GIS) in Pediatric Physiotherapy of the AIFI Italian Association of Physiotherapists (AIFI) has produced a brochure for parents on the prevention of POP.
Primary endpoint: to assess whether the educational intervention for the prevention of POP carried out by the physiotherapist, as part of the prenatal program, reduces the incidence of POP in infants at 3 months of age.
Secondary endpoints: to assess whether the educational intervention is effective in preventing the problems often associated with POP (postural torticollis, muscle contracture in the neck, benign scoliosis, immaturity in axial control).
Recently, interest has emerged in the possibility of preventing POP: studies have been conducted showing that preventive and educational intervention with families on the most appropriate ways of caring for their babies after birth effectively reduces the incidence and severity of POP in the first months of life and that good nationwide training of healthcare professionals on this topic could help minimize public healthcare costs.
The Specialist Interest Group (GIS) in Pediatric Physiotherapy of the AIFI Italian Association of Physiotherapists (AIFI) has produced a brochure for parents on the prevention of POP.
Primary endpoint: to assess whether the educational intervention for the prevention of POP carried out by the physiotherapist, as part of the prenatal program, reduces the incidence of POP in infants at 3 months of age.
Secondary endpoints: to assess whether the educational intervention is effective in preventing the problems often associated with POP (postural torticollis, muscle contracture in the neck, benign scoliosis, immaturity in axial control).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: