Cranial Asymmetry, Premature Newborns
Conditions
Keywords
Brachycephaly, Non-synostotic deformational plagiocephaly, Prematurity, Positional Plagiocephaly
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.
Detailed description
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.
Interventions
OTHERTummy Time Protocol
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 37 Weeks
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of cranial asymmetry | 1 days | Identification of cranial asymmetry measured through craniometry assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cranial asymmetry measured | 15 days | Cranial asymmetry measured before and after positioning protocol. |
| Risk of delayed motor development | 15 days | Risk of delayed motor development measured using the TIMP scale. |
Countries
Brazil
Contacts
CONTACTRoberta F. Sa Brito
CONTACTSilvia R Jandt
PRINCIPAL_INVESTIGATORRoberta FS Brito
physiotherapist
Outcome results
None listed