Premature NewbornsplagiocephalyNCT07758426
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
A study testing Tummy Time Protocol in people with Premature Newborns and Cranial Asymmetry, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time lying on their back. Read more about this study
- Who is it for?
- Ages Up to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Newborns, Cranial Asymmetry
- What is being tested?
- Tummy Time Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2026to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns with suspected cranial asymmetry.
- Newborns of both sexes.
- Gestational age of less than 37 weeks.
- Admission to the HCPA Neonatal ICU or Neonatal Intermediate Care Unit.
- Breathing without invasive ventilatory support and clinically stable, or breathing room air.
- No expected hospital discharge within the next 15 days.
Who cannot join
- Patients with congenital cranial malformations (e.g., hydrocephalus).
- Patients with chronic diseases that could compromise the assessment of cranial asymmetry.
- Patients with clinical conditions that prevent or compromise the performance of the procedures proposed in the study.
- Patients with prolonged hospital stays requiring transfer to the Pediatric Intensive Care Unit (PICU) or the Pediatric Inpatient Unit (PIU).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Effects of Tummy Time Combined with Therapeutic Positioning., +55 51 992562535, rfbrito@hcpa.edu.br
About this study
Official title: Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time lying on their back. Premature babies are at higher risk of developing this alteration, especially those who are hospitalized for long periods in intensive care units and use respiratory support devices. This study aims to evaluate the effects of a physiotherapy protocol in premature newborns with cranial asymmetry. To this end, the babies will be divided into two groups: one will receive daily positioning exercises and tummy time, while the other will continue to receive the unit's usual physiotherapy care.
Read the detailed description
Deformational plagiocephaly (DP) specifically refers to cranial asymmetry due to external compression. These deformational changes are believed to originate in utero and are exacerbated by sleeping in the supine position. In the first weeks of a baby's life, it generally becomes more severe due to active head positioning, with a peak prevalence at 4 months of age. Prematurity is frequently cited as a risk factor, as are patients who remain hospitalized for extended periods in the intensive or semi-intensive care unit, in the supine position for prolonged periods, contributing to accelerated head deformation. Similarly, the use of non-invasive ventilatory support devices with a hood is also associated with an increase in DP cases. Therefore, the objective of this study is to verify the effects of a physiotherapy protocol in premature newborns with cranial asymmetry. This is a randomized, controlled clinical trial composed of premature newborns under 37 weeks of gestation diagnosed with cranial asymmetry of both sexes who are hospitalized in the NICU and PICU of the Hospital de Clínicas de Porto Alegre, for a period of 15 days. Patients will be randomized into an intervention group consisting of a daily tummy time and positioning protocol, and a control group that will maintain the unit's usual physiotherapy routine.
- Conditions
- Premature Newborns, Cranial Asymmetry
- Being tested
- Tummy Time Protocol
- Keywords
- Brachycephaly, Non-synostotic deformational plagiocephaly, Prematurity, Positional Plagiocephaly
- Medical subject headings
- Craniosynostoses, Premature Birth, Plagiocephaly, Nonsynostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tummy Time ProtocolOther
The intervention team will implement a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes of daily tummy time, divided into 3 periods of 10 minutes each day (morning/afternoon and evening), combined with therapeutic positioning that preserves the flat side of the cranial asymmetry, for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| cranial asymmetry assessed in the intervention group | Experimental | The intervention group will carry out a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes daily, divided into 3 periods of 10 minutes, each shift (morning/afternoon and evening) of tummy time, associated with therapeutic positioning preserving the flat side of the cranial asymmetry, for 15 days. Receives: Other: Tummy Time Protocol |
| Cranial asymmetry assessed in the control group | No intervention | The control group will undergo routine physiotherapy follow-up at the unit, which consists of implementing the osteopenia prevention protocol for newborns under 32 weeks. The protocol consists of a daily program involving range of motion (ROM) exercises against resistance and extension and flexion of the upper and lower extremities. The exercises are performed on the wrists, elbows, shoulders, ankles, knees, and hip joints of the babies by a research team member. The daily exercise regimen is repeated 5-8 times, one session per shift, for 7-10 minutes, and includes alternating decubitus changes in addition to sensorimotor stimulation, which consists of unimodal (tactile, vestibular, olfactory, auditory, and visual), multimodal (tactile-kinesthetic, massage therapy, skin-to-skin contact, and multisensory) stimulation and mobilization exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cranial asymmetry
Identification of cranial asymmetry measured through craniometry assessment.
Measured: 1 days
Secondary outcomes (2)
Cranial asymmetry measured
Cranial asymmetry measured before and after positioning protocol.
Measured: 15 days
Risk of delayed motor development
Risk of delayed motor development measured using the TIMP scale.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will carry out a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes daily, divided into 3 periods of 10 minutes, each shift (morning/afternoon and evening) of tummy time, associated with therapeutic positioning preserving the flat side of the cranial asymmetry, for 15 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberta FS Brito, Principal investigator, physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758426
- Sponsor's protocol ID
- 2024-0498
- Acronym
- plagiocephaly
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will not be shared, in accordance with the General Data Protection Law (LGPD - Law No. 13.709/2018), which guarantees the privacy and protection of individuals' personal and sensitive information. As the data used in this study contains information related to the participants' health, access will be restricted to the responsible researchers, preserving the secrecy and confidentiality of the collected information.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07758426
- Acronym / sponsor ID
- plagiocephaly / 2024-0498
- Conditions
- Premature Newborns, Cranial Asymmetry
- Keywords
- Brachycephaly, Non-synostotic deformational plagiocephaly, Prematurity, Positional Plagiocephaly
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 11 Aug 2026 (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.
Deformational plagiocephaly is an alteration in the shape of a baby's head caused by pressure exerted on the skull. This condition can begin during gestation and worsen after birth, especially when the baby spends a lot of time lying on their back. Premature babies are at higher risk of developing this alteration, especially those who are hospitalized for long periods in intensive care units and use respiratory support devices. This study aims to evaluate the effects of a physiotherapy protocol in premature newborns with cranial asymmetry. To this end, the babies will be divided into two groups: one will receive daily positioning exercises and tummy time, while the other will continue to receive the unit's usual physiotherapy care.
Detailed description
Deformational plagiocephaly (DP) specifically refers to cranial asymmetry due to external compression. These deformational changes are believed to originate in utero and are exacerbated by sleeping in the supine position. In the first weeks of a baby's life, it generally becomes more severe due to active head positioning, with a peak prevalence at 4 months of age. Prematurity is frequently cited as a risk factor, as are patients who remain hospitalized for extended periods in the intensive or semi-intensive care unit, in the supine position for prolonged periods, contributing to accelerated head deformation. Similarly, the use of non-invasive ventilatory support devices with a hood is also associated with an increase in DP cases. Therefore, the objective of this study is to verify the effects of a physiotherapy protocol in premature newborns with cranial asymmetry. This is a randomized, controlled clinical trial composed of premature newborns under 37 weeks of gestation diagnosed with cranial asymmetry of both sexes who are hospitalized in the NICU and PICU of the Hospital de Clínicas de Porto Alegre, for a period of 15 days. Patients will be randomized into an intervention group consisting of a daily tummy time and positioning protocol, and a control group that will maintain the unit's usual physiotherapy routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group will carry out a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes daily, divided into 3 periods of 10 minutes, each shift (morning/afternoon and evening) of tummy time, associated with therapeutic positioning preserving the flat side of the cranial asymmetry, for 15 days.
| Arm | Type | Receives |
|---|---|---|
| cranial asymmetry assessed in the intervention group | Experimental | Other: Tummy Time ProtocolThe intervention group will carry out a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes daily, divided into 3 periods of 10 minutes, each shift (morning/afternoon and evening) of tummy time, associated with therapeutic positioning preserving the flat side of the cranial asymmetry, for 15 days. |
| Cranial asymmetry assessed in the control group | No intervention | –The control group will undergo routine physiotherapy follow-up at the unit, which consists of implementing the osteopenia prevention protocol for newborns under 32 weeks. The protocol consists of a daily program involving range of motion (ROM) exercises against resistance and extension and flexion of the upper and lower extremities. The exercises are performed on the wrists, elbows, shoulders, ankles, knees, and hip joints of the babies by a research team member. The daily exercise regimen is repeated 5-8 times, one session per shift, for 7-10 minutes, and includes alternating decubitus changes in addition to sensorimotor stimulation, which consists of unimodal (tactile, vestibular, olfactory, auditory, and visual), multimodal (tactile-kinesthetic, massage therapy, skin-to-skin contact, and multisensory) stimulation and mobilization exercises. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Newborns with suspected cranial asymmetry.
- Newborns of both sexes.
- Gestational age of less than 37 weeks.
- Admission to the HCPA Neonatal ICU or Neonatal Intermediate Care Unit.
- Breathing without invasive ventilatory support and clinically stable, or breathing room air.
Key exclusion criteria (4 listed)
- Patients with congenital cranial malformations (e.g., hydrocephalus).
- Patients with chronic diseases that could compromise the assessment of cranial asymmetry.
- Patients with clinical conditions that prevent or compromise the performance of the procedures proposed in the study.
- Patients with prolonged hospital stays requiring transfer to the Pediatric Intensive Care Unit (PICU) or the Pediatric Inpatient Unit (PIU).
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 |
|---|---|---|
| Tummy Time ProtocolThe intervention team will implement a specific protocol for the treatment of cranial asymmetry, consisting of 30 minutes of daily tummy time, divided into 3 periods of 10 minutes each day (morning/afternoon and evening), combined with therapeutic positioning that preserves the flat side of the cranial asymmetry, for 15 days. | Other | cranial asymmetry assessed in the intervention group |
Primary outcome
Identification of cranial asymmetry
Time frame: 1 days
Identification of cranial asymmetry measured through craniometry assessment.
2 secondary outcomes
Cranial asymmetry measured
Time frame: 15 days
Risk of delayed motor development
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Patient data will not be shared, in accordance with the General Data Protection Law (LGPD - Law No. 13.709/2018), which guarantees the privacy and protection of individuals' personal and sensitive information. As the data used in this study contains information related to the participants' health, access will be restricted to the responsible researchers, preserving the secrecy and confidentiality of the collected information.
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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.
Roberta FS Brito principal investigator
physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tummy Time Protocol in people with Premature Newborns and Cranial Asymmetry, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta F. Sa Brito (+5551992562535 ext. +5551 33598142, rfbrito@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cranial asymmetry (time frame: 1 days). 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 18 Sep 2026.