NCT07182604: POP2019

Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly

Completed NA Last updated 19 September 2025

What this trial tests

NA trial testing educational program on the POP prevention in Plagiocephaly, Positional in 400 participants. Completed in 30 April 2024.

Timeline

1 January 2023

Primary endpoint
12 December 2023

30 April 2024

Quick facts

Lead sponsor	Meyer Children's Hospital IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	400
Start date	1 January 2023
Primary completion	12 December 2023
Estimated completion	30 April 2024
Sites	1 location across Italy

Drugs / interventions tested

• educational program on the POP prevention

Conditions studied

• Plagiocephaly, Positional — all drugs for Plagiocephaly, Positional →

Sponsor

Meyer Children's Hospital IRCCS

Who can join

18 and older, any sex, with Plagiocephaly, Positional. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.