Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly

NCT07182604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-19

No results posted yet for this study

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).

Conditions

  • Plagiocephaly, Positional

Interventions

OTHER

educational 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 & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    collaborator OTHER
  • Azienda Ospedaliero-Universitaria di Parma

    collaborator OTHER
  • Ospedale Infermi Rimini

    collaborator UNKNOWN
  • Meyer Children's Hospital IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-12
Completion
2024-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182604 on ClinicalTrials.gov