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Completed

NCT Number: NCT07182604

Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viola Fortini

Florence, FI, 50139, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

educational program on the POP prevention

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.

Primary outcomes

  1. Difference in the ODDI index measured with a craniometer

    Time frame: 0,3 months post born

Secondary outcomes

  1. Difference in number of children affected by torticollis, benign scoliosis, axial immaturity in control group and intervention group

    Time frame: 0,3 months afther birth

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda Ospedaliero-Universitaria di Parma
  • Ospedale Infermi Rimini

Registry information

Official study title

Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly: a Randomized Multicenter Controlled Trial

Acronym: POP2019

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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