Plagiocephaly, PositionalPOP2019NCT07182604
Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly
A study testing educational program on the POP prevention in people with Plagiocephaly, Positional, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plagiocephaly, Positional
- What is being tested?
- educational program on the POP prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation of parents in the prenatal course at 34-38 weeks of gestation;
- Signing of the informed consent form;
Who cannot join
- 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%;
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- clavicle fractures;
- congenital clubfoot, metatarsus varus;
- congenital spinal and pelvic abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly: a Randomized Multicenter Controlled Trial
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.
Read more
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
- Being tested
- educational program on the POP prevention
- Keywords
- plagiocephaly positional, prevention
- Medical subject headings
- Plagiocephaly, Nonsynostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program on the POP preventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Parents who received the educational program on POP prevention Receives: Other: educational program on the POP prevention |
| Standard of care | No intervention | Parents who do not received the educational program on POP prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the ODDI index measured with a craniometer
Measured: 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
Measured: 0,3 months afther birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jan 2023
- Primary completion12 Dec 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plagiocephaly, PositionalStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero-Universitaria di Parma, Ospedale Infermi Rimini
- Responsible party
- Principal investigator, Viola Fortini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182604
- Sponsor's protocol ID
- POP2019
- Acronym
- POP2019
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Prenatal Educational Intervention to Prevent Positional Occipital Plagiocephaly: a Randomized Multicenter Controlled Trial
- ClinicalTrials.gov ID
- NCT07182604
- Acronym / sponsor ID
- POP2019 / POP2019
- Conditions
- Plagiocephaly, Positional
- Keywords
- plagiocephaly positional, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero-Universitaria di Parma, Ospedale Infermi Rimini
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: educational program on the POP preventionParents who received the educational program on POP prevention |
| Standard of care | No intervention | –Parents who do not received the educational program on POP prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation of parents in the prenatal course at 34-38 weeks of gestation;
- Signing of the informed consent form;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program on the POP preventionDuring 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. | Other | Experimental group |
Primary outcome
Difference in the ODDI index measured with a craniometer
Time frame: 0,3 months post born
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Plagiocephaly, Positional
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Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program on the POP prevention in people with Plagiocephaly, Positional, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the ODDI index measured with a craniometer (time frame: 0,3 months post born). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.