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

NCT07758426 | Not Yet Recruiting

• 1 other identifier: 2024-0498
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Newborns; Cranial Asymmetry

Keywords

Brachycephaly; Non-synostotic deformational plagiocephaly; Prematurity; Positional Plagiocephaly

Outcome Measures

Primary Outcomes (1)

• Identification of cranial asymmetry

  Identification of cranial asymmetry measured through craniometry assessment.

  1 days

Secondary Outcomes (2)

• Cranial asymmetry measured

  15 days

• Risk of delayed motor development

  15 days

Study Arms (2)

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.

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.

Interventions

Tummy Time Protocol OTHER

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.

cranial asymmetry assessed in the intervention group

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Craniosynostoses; Premature Birth; Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Plagiocephaly

Study Officials

• Roberta FS Brito

  physiotherapist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta F. Sa Brito

CONTACT

+5551992562535; rfbrito@hcpa.edu.br

Silvia R Jandt

CONTACT

+555196952410; sjandt@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 30, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)