An interventional study of Tummy Time Protocol in Premature Newborns and Cranial Asymmetry, sponsored by Hospital de Clinicas de Porto Alegre. Not yet recruiting at 1 site in Brazil. Open to participants aged Up to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 300 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.
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Exclusion criteria
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.
Other: Tummy Time Protocol
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.
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.
Identification of cranial asymmetry
Identification of cranial asymmetry measured through craniometry assessment.
Time frame: 1 days
Cranial asymmetry measured
Cranial asymmetry measured before and after positioning protocol.
Time frame: 15 days
Risk of delayed motor development
Risk of delayed motor development measured using the TIMP scale.
Time frame: 15 days
Plan to share: 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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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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