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NCT Number: NCT07758426

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Identification of cranial asymmetry

    Time frame: 1 days

    Identification of cranial asymmetry measured through craniometry assessment.

Secondary outcomes

  1. Cranial asymmetry measured

    Time frame: 15 days

    Cranial asymmetry measured before and after positioning protocol.

  2. Risk of delayed motor development

    Time frame: 15 days

    Risk of delayed motor development measured using the TIMP scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Roberta F. Sa Brito

CONTACT

[email protected]

+5551992562535 ext. +5551 33598142

Silvia R Jandt

CONTACT

[email protected]

+555196952410 ext. +5551 33598142

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial

Acronym: plagiocephaly

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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