Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry (plagiocephaly)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Newborns; Cranial Asymmetry
• Intervention / Treatment: Other: Tummy Time Protocol

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta F. Sa Brito; Phone Number: +5551 33598142 +5551992562535; Email: rfbrito@hcpa.edu.br
• Study Contact Backup: Name: Silvia R Jandt; Phone Number: +5551 33598142 +555196952410; Email: sjandt@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre
      • Contact: Effects of Tummy Time Combined with Therapeutic Positioning.; Phone Number: +55 51 992562535; Email: rfbrito@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cranial asymmetry assessed in the intervention group; 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 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.
No Intervention: Cranial asymmetry assessed in the control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of cranial asymmetry	Identification of cranial asymmetry measured through craniometry assessment.	1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cranial asymmetry measured	Cranial asymmetry measured before and after positioning protocol.	15 days
Risk of delayed motor development	Risk of delayed motor development measured using the TIMP scale.	15 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Roberta FS Brito, physiotherapist

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 30, 2030

Study Registration Dates

• First Submitted: August 6, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Prematurity; Positional Plagiocephaly; Brachycephaly; Non-synostotic deformational plagiocephaly
• Additional Relevant MeSH Terms: Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Plagiocephaly; Premature Birth; Craniosynostoses; Plagiocephaly, Nonsynostotic
• Other Study ID Numbers: 2024-0498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No