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Can simple tummy time reshape a Preemie's head?

NCT ID NCT07758426

Disease control Sponsor: Hospital de Clinicas de Porto Alegre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This trial tests whether a daily routine of tummy time and careful positioning can help correct cranial asymmetry—a flattened head shape—in premature newborns. About 300 babies born before 37 weeks who are in the neonatal ICU or intermediate care unit will be split into two groups: one receives the special positioning protocol for 15 days, while the other gets standard physiotherapy. Researchers will measure head shape before and after, and also check for signs of delayed motor development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A physiotherapy protocol combining daily tummy time (30 minutes split into three 10-minute sessions) with therapeutic positioning that avoids the flattened side of the head, delivered over 15 days.
What this could lead to
If effective, this simple, drug-free protocol could offer a practical way to improve head shape and potentially reduce the risk of motor development delays in premature infants with cranial asymmetry.
What could go wrong
The trial is relatively small and the intervention is short-term, so benefits may be modest or not lasting. The study also focuses on hospitalized preemies, so results may not apply to all infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 37 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

craniosynostosis Plagiocephaly, Nonsynostotic Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cranial asymmetry Premature newborns

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

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