[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651181":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":40,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"cranial asymmetry assessed in the intervention group","EXPERIMENTAL","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\u002Fafternoon and evening) of tummy time, associated with therapeutic positioning preserving the flat side of the cranial asymmetry, for 15 days.",[13],"Other: Tummy Time Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Cranial asymmetry assessed in the control group","NO_INTERVENTION","The control group will undergo routine physiotherapy follow-up at the unit, which consists of implementing the osteopenia prevention protocol for newborns under 32 weeks. The protocol consists of a daily program involving range of motion (ROM) exercises against resistance and extension and flexion of the upper and lower extremities. The exercises are performed on the wrists, elbows, shoulders, ankles, knees, and hip joints of the babies by a research team member. The daily exercise regimen is repeated 5-8 times, one session per shift, for 7-10 minutes, and includes alternating decubitus changes in addition to sensorimotor stimulation, which consists of unimodal (tactile, vestibular, olfactory, auditory, and visual), multimodal (tactile-kinesthetic, massage therapy, skin-to-skin contact, and multisensory) stimulation and mobilization exercises.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Tummy 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\u002Fafternoon and evening), combined with therapeutic positioning that preserves the flat side of the cranial asymmetry, for 15 days.",[9],[25],{"name":26,"affiliation":27,"role":28},"Roberta FS Brito","physiotherapist","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Roberta F. Sa Brito","CONTACT","+5551992562535","+5551 33598142","rfbrito@hcpa.edu.br",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Silvia R Jandt","+555196952410","sjandt@hcpa.edu.br",[41],{"facility":5,"status":18,"city":42,"state":43,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":47,"coordinates":48},"Point",[49,50],-51.23019,-30.03283,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":18,"email":35},"Effects of Tummy Time Combined with Therapeutic Positioning.","+55 51 992562535",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100651181","effects-of-tummy-time-associated-with-therapeutic-positioning-in-premature-newborns-with-cranial-asymmetry-100651181",false,"NCT07758426","Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry","Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry: A Randomized Clinical Trial","plagiocephaly","Inclusion criteria\n\n* Newborns with suspected cranial asymmetry.\n* Newborns of both sexes.\n* Gestational age of less than 37 weeks.\n* Admission to the HCPA Neonatal ICU or Neonatal Intermediate Care Unit.\n* Breathing without invasive ventilatory support and clinically stable, or breathing room air.\n* No expected hospital discharge within the next 15 days.\n\nExclusion criteria\n\n* Patients with congenital cranial malformations (e.g., hydrocephalus).\n* Patients with chronic diseases that could compromise the assessment of cranial asymmetry.\n* Patients with clinical conditions that prevent or compromise the performance of the procedures proposed in the study.\n* Patients with prolonged hospital stays requiring transfer to the Pediatric Intensive Care Unit (PICU) or the Pediatric Inpatient Unit (PIU).",true,"ALL","37 Weeks",{"count":70,"type":71},300,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.",[77,78],"Premature Newborns","Cranial Asymmetry",[80,81,82,83],"Brachycephaly","Non-synostotic deformational plagiocephaly","Prematurity","Positional Plagiocephaly","NOT_YET_RECRUITING","2026-08-06",{"date":87,"type":88},"2026-08-11","ACTUAL",{"date":90,"type":71},"2026-08",{"date":92,"type":71},"2030-01-30",{"name":5,"class":6},1]