Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Location contact
Effects of Tummy Time Combined with Therapeutic Positioning.
CONTACT
NCT Number: NCT07758426
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.
Trial opening soon.
Get NotifiedUp to 37 week
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, Brazil
Effects of Tummy Time Combined with Therapeutic Positioning.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 days
Identification of cranial asymmetry measured through craniometry assessment.
Time frame: 15 days
Cranial asymmetry measured before and after positioning protocol.
Time frame: 15 days
Risk of delayed motor development measured using the TIMP scale.
Contact information is provided by the study sponsor or research team.
Roberta F. Sa Brito
CONTACT
+5551992562535 ext. +5551 33598142
Silvia R Jandt
CONTACT
+555196952410 ext. +5551 33598142
Hospital de Clinicas de Porto Alegre
Other
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial
Acronym: plagiocephaly
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