[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Oulu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":298},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,83,116,144,167,189,217,245,274],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622308","the-effect-of-consumed-berries-on-extracellular-vesicle-signalling-in-the-body-100622308",false,"NCT07381933","The Effect of Consumed Berries on Extracellular Vesicle Signalling in the Body","NutriEV RCT","Inclusion Criteria:\n\n* Age 18-50\n* Individuals of all heights and weights and both female and male sexes are accepted\n* Written informed consent is required from all study participants\n* Use of probiotics is allowed, but the usage will be reported\n\nExclusion Criteria:\n\n* Known or suspected allergy to cloudberries or lingonberries\n* Current dermatological or gastrointestinal conditions requiring treatment or interfering the sampling\n* Renal failure\n* Type 1 or type 2 diabetes\n* Pregnancy\n* Immunodeficiency or any condition affecting the immune system, e.g. chronic viral infection\n* Ongoing antibiotic treatment or antibiotic treatment within the past 3 months\n* Immunosuppressive medication or other medication that can be influenced by the intervention",true,"ALL","18 Years","50 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study examines how berry consumption influences the signaling and distribution of extracellular vesicles (EVs) in the human body. EVs are small bilipid-layered nanoparticles released by cells. EVs carry proteins, lipids, and genetic material, and play a key role in cell-to-cell communication. The composition of EVs reflects the state of their cells of origin, and EVs can affect other cells by delivering their biological contents. EVs offer significant potential for both diagnostics and new therapies.\n\nRecent research has shown that EVs can be found in blood, urine, sweat, and can even cross biological barriers such as the blood-brain barrier and placenta. Many living organisms, including mammalian cells, bacteria, and plants, release EVs. Berries such as cloudberries and lingonberries have demonstrated positive effects on gut microbiota and metabolism, supporting digestive and metabolic health.\n\nIn this study, a nutritional intervention will be conducted to investigate the effects of berry consumption on extracellular vesicle signaling of human cells and the gut microbiota, as well as the biodistribution of berry-derived vesicles in the human body.",[28,29],"Healthy","Extracellular Vesicles",[31],"extracellular vesicles","RECRUITING","2026-06-08",{"date":35,"type":36},"2026-06-09","ACTUAL",{"date":38,"type":36},"2026-01-23",{"date":40,"type":22},"2026-12-31",{"name":42,"class":43},"University of Oulu","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100614517","diagnostic-pcr-panel-in-children-with-acute-gastrointestinal-symptoms-100614517","NCT07280624","Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms","Clinical Significance of Real Time PCR Panel in Children With Acute Gastrointestinal Symptoms","RealCAGI RCT","Inclusion Criteria:\n\n* Child or adolescent \\\u003C 16 years of age\n* Visiting pediatric ED\n* Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)\n\nExclusion Criteria:\n\n* Need of cardiopulmonary resuscitation at the ED\n* Need of immediate transfer to the intensive care unit\n* Hemato-oncological disease\n* Severe immunosuppression\n* Bloody diarrhea\n* Clinical suspicion of typhoid\u002Fparatyphoid fever","16 Years",{"count":55,"type":22},526,[25],"This investigator-initiated randomized controlled trial compares the clinical impact of real time PCR of fecal samples in children with acute gastrointestinal symptoms at a pediatric emergency room. Specifically, the trial compares immediate testing of fecal samples using a multiplex PCR panel to a a control group with delayed test results.",[59,60,61,62],"Gastroenteritis Acute","Gastrointestinal Symptoms","Abdominal Pain\u002F Discomfort","Vomiting in Infants and\u002For Children",[64,65,66,67,68,69,70,71,72,73],"Multiplex PCR","Fecal samples","Diagnostic stewardship","Diarrhea","Vomiting","Abdominal pain","Gastrointestinal symptoms","Pediatrics","Children","Emergency department","NOT_YET_RECRUITING","2025-12-09",{"date":77,"type":36},"2025-12-12",{"date":79,"type":22},"2025-12-15",{"date":81,"type":22},"2028-02-15",{"name":42,"class":43},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100611083","new-therapeutic-interventions-and-imaging-techniques-for-prolonged-shoulder-disorders-100611083","NCT07235969","New Therapeutic Interventions and Imaging Techniques for Prolonged Shoulder Disorders","A Single-center, Randomized, Parallel-group Study to Compare the Efficacy of Psychologically Informed Physical Therapy, Tendon-Specific Exercise Program and Routine Physical Therapy in Prolonged Unilateral Shoulder Pain: RESSPECT Study","RESSPECT","Inclusion Criteria:\n\n* Age of 20-60 years\n* Active participation in the workforce (employed or entrepreneur)\n* Active occupational health care services available\n* Daily unilateral shoulder pain for at least four consecutive weeks\n* Willingness to participate in independent rehabilitation and PT visits\n\nExclusion Criteria:\n\n* Bilateral shoulder pain\n* Previous humerus fracture or current acute upper limb injury\n* Prolonged dysfunction or pain of the upper limb attributable to trauma, neurologic disease or cervical spine disorders\n* Diagnosed musculoskeletal disorders affecting the upper limb (e.g. rheumatoid arthritis)\n* Severe disability, mental or memory disorder\n* Advanced cancer\n* History of shoulder PT or corticosteroid injection in the last six months\n* Previous or planned shoulder surgery\n* Confirmed or possible pregnancy\n* Contraindications to MRI\n* Severe chronic kidney disease\n* Evidence unaccounted malignancy or other exclusionary findings in the initial eligibility assessment on either side","20 Years","60 Years",{"count":94,"type":22},300,[25],"The RESSPECT study compares three types of physical therapy for adults aged 20-60 years with prolonged shoulder disorders, aiming to find better ways to help people recover and improve daily function. The study also examines modern imaging tests (X-ray, ultrasound, MRI) to see how well imaging findings match real symptoms, and tests new imaging technologies that may provide a more accurate diagnosis. The study improves future shoulder pain care by addressing both physical and psychological factors and advancing diagnostic imaging.\n\nParticipants are randomly assigned to one of three groups:\n\n1. Routine physical therapy (usual occupational care),\n2. Tendon-Specific Exercise Program (TSEP): targeted exercises to build shoulder strength and\n3. Psychologically Informed Physical Therapy (PIPT): combining physical rehabilitation with advice and emotional support.\n\nAll participants get complete imaging of both shoulders and a clinical evaluation by a physiotherapist at the start of the study. Complete imaging is also done for all participants after twelve months. Surveys about pain, movement, mood, sleep, and quality of life are collected electronically at the start of the study, and at three, six, twelve, and 36 months. The main outcome is how well each person resumes everyday activities affected by shoulder pain (Patient-Specific Functional Scale, PSFS).\n\nGroup 1 will receive routine occupationally led physiotherapy, and groups 2 and 3 will receive five physiotherapist-guided sessions during the first six month-period. Advanced imaging techniques will deployed in conjunction with standard imaging methods and compared to see whether new technologies help explain symptoms or guide care.\n\nTo join, participants must have had prolonged shoulder disorders in one shoulder for at least four consecutive weeks, be employed or self-employed, and be willing to take part in rehabilitation activities. Certain medical conditions, prior surgery, and pregnancy are exclusion criteria. Inclusion and exclusion criteria are systematically reviewed in a structured phone interview at the start of the study. Baseline imaging is also viewed preliminarily for certain conditions which would require urgent medical care. If necessary, participants are contacted, informed and subsequently excluded from the study.\n\nThe trial takes place at Oulu University Hospital, Finland. Approximately 300 people are recruited to the study via local ads. Informed consent is required for the study, and participants can withdraw at any time. All procedures meet ethical standards.\n\nThis study will help determine:\n\n1. Which therapy works best overall\n2. Whether some people benefit more from certain therapies\n3. If imaging findings help predict outcomes or aid treatment decisions\n4. Whether new imaging technology improves diagnosis",[98,99,100],"Shoulder Pain","Pain Management","Physical Therapy",[99,102,103,104,105,106,107],"Psychologically Informed Physical Therapy","Magnetic resonance fingerprinting","Diagnostic Imaging","Microvascular Flow Imaging","Tendon-Specific Exercise Program","Shear Wave Elastography","2025-11-14",{"date":110,"type":36},"2025-11-19",{"date":112,"type":22},"2026-01",{"date":114,"type":22},"2029-01",{"name":42,"class":43},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":143,"locationsCount":44},"100477262","effectiveness-of-multisensoral-nature-based-intervention-in-hospitalized-children-during-venous-blood-sampling-100477262","NCT05494684","Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling","Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. The child is aged between 5 and 9 years old\n2. The child has a long-term illness (such as diabetes or rheumatism)\n3. The child has previous experience of venous blood sampling\n4. The child's level of development is age-appropriate (such as, the child is cared for at home or in day care\u002Fday nursery or attends school in the same level as the other children)\n5. Child and parent understand and speak the Finnish language\n\nExclusion Criteria:\n\n1. The child has a diagnosis of abnormal neurological development (such as, a child has difficulty understanding spoken language or expressing emotions)\n2. The child has chronic pain that has lasted more than 3 months and requires strong painkillers (opiates).\n3. The child undergoes an examination or treatment during a check-up at the outpatient clinic that requires medical treatment similar to anesthesia\n4. The child is taking a sedative medication.","5 Years","9 Years",{"count":126,"type":22},53,[25],"This randomized controlled trial (RCT) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling.",[130,131,132,133],"Anxiety","Fear","Pain","Satisfaction",[72,135,136],"Nature-based Intervention","Venipuncture","2025-03-31",{"date":139,"type":36},"2025-04-04",{"date":141,"type":22},"2025-08-01",{"date":40,"type":22},{"name":42,"class":43},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":44},"100523248","video-assisted-study-of-salbutamol-response-in-viral-wheezing-100523248","NCT06093152","Video Assisted Study of Salbutamol Response in Viral Wheezing","ViVi","Inclusion Criteria:\n\n* Wheezing\n* Salbutamol-treatment in emergency department prescribed\n\nExclusion Criteria:\n\n* Need for immediate resuscitation\n* Immediate transfer to ICU\n* Suspicion of pneumonia based on the auscultation finding\n* Suspicion of airway foreign body","6 Months","24 Months",{"count":154,"type":22},50,"OBSERVATIONAL","The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.",[158],"Wheezing","2025-02-11",{"date":161,"type":36},"2025-02-13",{"date":163,"type":36},"2023-10-23",{"date":165,"type":22},"2026-12",{"name":42,"class":43},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":152,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100473423","phase-4-oral-prednisolone-for-acute-rhinovirus-induced-wheezing-in-children-less-than-2-years-of-age-100473423","NCT05444699","Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age","Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial","RhinoPOCRCT","Inclusion Criteria:\n\n* Wheezing bronchitis diagnosed by a physician\n* Need for salbutamol treatment at the emergency department\n* Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing\n\nExclusion Criteria:\n\n* Need for immediate resuscitation\n* Immediate transfer to ICU\n* Suspected pneumonia based on the auscultation finding\n* Suspected serious bacterial infection\n* Other respiratory virus finding in the absence of rhinovirus or picornavirus\n* Positive respiratory syncytial virus finding\n* Positive SARS-coronavirus-2 finding\n* Positive Mycoplasma pneumoniae finding\n* Positive Bordetella pertussis finding\n* Contact with a person with chickenpox within 14 days\n* Active chickenpox\n* Suspected foreign body of the respiratory tract\n* Immunosuppressive treatment\n* Systemic corticosteroid treatment within 14 days\n* Allergy to corticosteroids",{"count":176,"type":22},210,[178],"PHASE4","The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.",[181],"Bronchiolitis Acute Viral",{"date":161,"type":36},{"date":184,"type":36},"2022-10-11",{"date":186,"type":22},"2027-09",{"name":42,"class":43},2,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":197,"minAge":18,"maxAge":19,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":44},"100453022","robotic-versus-laparoscopic-surgery-for-deep-endometriosis-100453022","NCT05179109","Robotic Versus Laparoscopic Surgery for Deep Endometriosis","Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial","ROBEndo","Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists physical status classification) 1-3\n* Diagnosed deep endometriosis (MRI)\n* Patient has symptoms\n* Operative treatment is indicated\n* Patient is able to give informed consent\n\nExclusion Criteria:\n\n* ASA \\> 3\n* Recurring rectosigmoid endometriosis","FEMALE",{"count":199,"type":22},70,[25],"The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.",[203,204,205],"Endometriosis","Deep Endometriosis","Surgery",[207,208,209],"Endometriosis surgery","Deep endometriosis surgery","Robotic surgery","2024-12-03",{"date":212,"type":36},"2024-12-06",{"date":214,"type":36},"2022-10-03",{"date":40,"type":22},{"name":42,"class":43},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":16,"sex":17,"minAge":225,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":44},"100570757","the-effectiveness-of-exergaming-for-older-people-mobility-and-balance-100570757","NCT06711393","The Effectiveness of Exergaming for Older People Mobility and Balance","The Effectiveness of Exergaming (YetiHome®) Versus Traditional Exercise for Older People Mobility and Balance: Protocol of the Randomized Intervention Trial","YetiExergame","Inclusion Criteria:\n\n* Living at home.\n* Not a user of health and social services.\n* Sufficient cognitive ability to do exercises independently.\n\nExclusion Criteria:\n\n* Risk of hip fracture and inability to perform exercise independently.","75 Years",{"count":227,"type":22},100,[25],"The mobility problems of older people are often related to the decrease of functional capacity and health \\[1\\], weakened physical condition, attitude to life and fear of falling \\[2\\]. Relatively little research has been done on the possibilities and effectiveness of exergaming on the mobility of old people. Interventions that include exergaming have been found to motivate and increase commitment to rehabilitation \\[3\\], to improve mobility, balance \\[4\\], performance in daily activities and independence \\[5\\].\n\nThe aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home.\n\nThis study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27\" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home.\n\nThe aim of randomized intervention trial is to find out the effect of physical exercises performed on the technological device (YetiHome®) on identified preclinical movement problems during a 2-month follow-up period. The goal is to produce information about the effectiveness of gamified physical exercises in preventing movement problems and supporting older people living at home.\n\nThis study investigates the effectiveness of the YetiHome in improving the physical functioning of older people. YetiHome is an assistive technology device developed for special groups. YetiHome is a small interactive touchscreen tablet with 27\" screen and with Android operating system and it includes numerous applications. Added exergaming solution for the balance training. There is no previous scientific research on the effectiveness of the YetiHome on the mobility problems and activity of the community-dwelling older people living independently at home.",[231],"Mobility Limitation",[233,234,235,236],"Older adults","Balance","Mobility limitation","Preclinical mobility limitation","2024-11-29",{"date":239,"type":36},"2024-12-02",{"date":241,"type":22},"2024-11-27",{"date":243,"type":22},"2025-02-28",{"name":42,"class":43},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":44},"100327919","effects-of-patient-centered-telephone-education-in-day-surgery-100327919","NCT03549403","Effects of Patient-centered Telephone Education in Day Surgery","Effects of Patient-centered Pre- and Postoperative Telephone Education on the Experienced Health and Health-care Costs in Day Surgery by Adult Patients: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* arrive at the surgery from home\n* leave latest at the next morning of the surgery\n* leave home after surgery\n* is 18-64 years old\n* be able to respond to the questionnaire independently.\n\nExclusion Criteria:\n\n* over 65 years old patients\n* patients who need institutional care after surgery\n* patients who arrive to surgery from a institutional care unit","64 Years",{"count":254,"type":22},120,[25],"This study describe and evaluate the effectiveness of patient-centered telephone education in day surgery. The aim is to evaluate the effects of patient-centered telephone education on the experienced health of adult patients and the costs of healthcare in day surgery. Telephone education intervention is planned in co-operation with the day surgery unit´s healthcare staff.\n\nHalf of participants will receive current education in day surgery, while the other half will receive developed patient-centered telephone education before and after day surgery.",[258,259],"Health, Subjective","Cost Effectiveness",[261,262,263,264,265,266],"Telephone education","Effectiveness","Health","Cost","Day surgery","Adult patient","2023-11-28",{"date":269,"type":36},"2023-11-29",{"date":271,"type":22},"2024-09-01",{"date":165,"type":22},{"name":42,"class":43},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":44},"100342205","phase-4-premedication-for-less-invasive-surfactant-administration-100342205","NCT03735563","Premedication for Less Invasive Surfactant Administration","LISA-Med","Inclusion Criteria:\n\n* Gestational age at birth ≥26 weeks\n* Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)\n* Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician's assessment)\n* If further doses of surfactant are needed, patient can be re-randomized\n\nExclusion Criteria:\n\n* Severe RDS with high oxygen requirements, severe respiratory acidosis and\u002For widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy (intubation in preferable to LISA if FiO2 \\>40% at GA \\\u003C28 weeks and \\>60% at GA ≥28 weeks)\n* Maxillo-facial, tracheal or known pulmonary malformations\n* Any known chromosomal abnormality or severe malformation\n* An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)",{"count":282,"type":22},40,[178],"Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of \"soft landing\" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.",[286],"Surfactant Deficiency Syndrome Neonatal",[288,289],"less invasive surfactant administration","premedication","2023-06-02",{"date":292,"type":36},"2023-06-05",{"date":294,"type":36},"2019-02-11",{"date":296,"type":22},"2026-10-31",{"name":42,"class":43},""]