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NCT07758426
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Conditions: Premature Newborns, Cranial Asymmetry
Sex: All
Ages: N/A – 37 Weeks
Healthy volunteers: Yes
Phase: NA
Enrollment: 300
Sponsor: Hospital de Clinicas de Porto Alegre
Location: Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
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.
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT07758426). StuddyBuddy aggregates publicly available trial information.