Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 37
SponsorHospital de Clinicas de Porto Alegre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tummy Time Protocol

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: cranial asymmetry assessed in the intervention groupExperimental treatment 1 intervention
Group B: Cranial asymmetry assessed in the control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Identification of cranial asymmetry

Identification of cranial asymmetry measured through craniometry assessment.

Time frame
1 days

Secondary outcomes

1

Cranial asymmetry measured

Cranial asymmetry measured before and after positioning protocol.

Time frame
15 days
2

Risk of delayed motor development

Risk of delayed motor development measured using the TIMP scale.

Time frame
15 days

Other outcomes

Sponsors and contacts

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