[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-newborns\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-newborns":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Premature Newborns","Cranial Asymmetry",[31,32,33,34],"Brachycephaly","Non-synostotic deformational plagiocephaly","Prematurity","Positional Plagiocephaly","NOT_YET_RECRUITING","2026-08-06",{"date":38,"type":39},"2026-08-11","ACTUAL",{"date":41,"type":22},"2026-08",{"date":43,"type":22},"2030-01-30",{"name":45,"class":46},"Hospital de Clinicas de Porto Alegre","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100531504","pain-relief-in-premature-newborns-through-maternal-intervention-during-venipuncture-100531504","NCT06200662","Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture","Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture: Effectiveness, Experiences of Parents and Carers","PREMAMANDOL","Inclusion Criteria:\n\n* Very premature babies born before the gestational age (GA) of 32 weeks of amenorrhoea (SA) whose corrected age (CA) does not exceed 34 SA at the time of their participation.\n* NN requiring close biological monitoring by a PV.\n* Hospitalised in the NN medicine and intensive care unit at Strasbourg hospital.\n* Consent obtained from both holders of parental authority.\n* Person covered by a social health insurance scheme.\n\nExclusion Criteria:\n\n* Any known malformation affecting one or more organs.\n* Cerebral lesions discovered o n cerebral ultrasound (intraventricular haemorrhage grade \\> 2, periventricular leukomalacia).\n* Unstable clinical state as judged by the investigator and the medical team.\n* Transfer to another hospital centre expected before the end of the study period.\n\n  * Mother: Minor. Deprived of liberty by judicial or administrative decision. Under legal protection. Severe psychological pathology. Drug addiction. Difficulty understanding and\u002For reading the language.\n\nFrench.","32 Weeks","34 Weeks",{"count":59,"type":22},48,[25],"Extremely premature newborn infants (ELNs) admitted to hospital are exposed to stressful and painful stimuli, and often to maternal separation, which can affect their long-term neurological development. Child- and family-centred developmental care (CFDC) in neonatology aims to adapt the hospital environment to the needs of the child, support the continued presence of the family and help to improve their future.\n\nSpecific assessment and appropriate analgesic treatment are therefore priorities for preserving the well-being and cerebral development of this population, which is particularly vulnerable to pain. Pain relief for certain procedures necessary for the care of newborn babies, such as venipuncture (PV), remains inadequate. Venipuncture is a common procedure in the first few weeks of life for very premature newborns. Its analgesic treatment is based on non-medicinal strategies largely carried out in the nurse's own role: non-nutritive suctioning combined with the administration of a sugar solution and wrapping. In line with the SDCEF philosophy, and reinforced by the \"zero separation\" concept, parental involvement in the treatment of their newborn's pain becomes natural and fundamental. A number of studies have shown the benefits of parents' presence and participation through specific isolated analgesic actions. Skin- to-skin contact (PAP) is one of these and has multiple benefits for the newborn. However, in practice, when a PV is necessary for a very premature baby, its use as a pain-relieving strategy is hampered by a number of obstacles. As NN are naturally oriented towards the maternal voice, using it is a new approach to analgesia. In an innovative study carried out in a single centre, direct maternal voice contact, in addition to the usual non- pharmacological analgesic strategies, reduced the NN's pain, without completely eliminating it during heel sampling (a skin incision known to be more painful than a PV). This analgesic strategy should therefore be combined with other non-pharmacological strategies, taking advantage of all maternal skills.",[28],"RECRUITING","2026-06-05",{"date":66,"type":39},"2026-06-09",{"date":68,"type":39},"2024-02-22",{"date":70,"type":22},"2028-02-07",{"name":72,"class":46},"University Hospital, Strasbourg, France"]