About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Tummy Time Protocol
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Identification of cranial asymmetry
Identification of cranial asymmetry measured through craniometry assessment.
Secondary outcomes
Cranial asymmetry measured
Cranial asymmetry measured before and after positioning protocol.
Risk of delayed motor development
Risk of delayed motor development measured using the TIMP scale.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: