Plagiocephaly, Positional
Conditions
Keywords
plagiocephaly positional, prevention
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).
Interventions
OTHEReducational program on the POP prevention
During a regular prenatal class meeting, parents belonging to this group received information about POP and how to prevent it (a presentation by a physiotherapist, a video shown to all centers participating in the study, practical demonstrations of activities using a doll, and a brochure with prevention tips). The children were then assessed at birth to rule out congenital disorders and at 3 months to detect any POP and associated postural problems. They were then sent a questionnaire to assess their perceived quality of the educational intervention carried out by the physiotherapist during the prenatal course.
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria di Parma
Ospedale Infermi Rimini
Meyer Children's Hospital IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multicenter, randomized intervention study with a 1:1 ratio, with cluster randomization of the dates of the monthly prenatal courses, carried out by the coordinating center for each satellite center, using a computerized system; with blinded evaluator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participation of parents in the prenatal course at 34-38 weeks of gestation; * Signing of the informed consent form;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the ODDI index measured with a craniometer | 0,3 months post born |
Secondary
| Measure | Time frame |
|---|---|
| Difference in number of children affected by torticollis, benign scoliosis, axial immaturity in control group and intervention group | 0,3 months afther birth |
Countries
Italy
Outcome results
None listed