Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly

NCT ID: NCT07182604

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-04-30

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).

Conditions

Plagiocephaly, Positional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Parents who received the educational program on POP prevention

Group Type: EXPERIMENTAL

educational program on the POP prevention

Intervention Type: OTHER

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.

Standard of care

Parents who do not received the educational program on POP prevention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: collaborator

Ospedale Infermi Rimini

UNKNOWN

Sponsor Role: collaborator

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Viola Fortini

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Viola Fortini

Florence, FI, Italy

Countries

Italy

Other Identifiers

POP2019

Identifier Type: -

Identifier Source: org_study_id