[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511706":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":104,"studyPopulation":98,"armGroups":105,"interventions":118,"overallOfficials":98,"centralContacts":127,"locations":137,"responsibleParty":724,"collaborators":727,"id":731,"slug":732,"hasResults":733,"nctId":734,"briefTitle":735,"officialTitle":736,"acronym":737,"eligibilityCriteria":738,"healthyVolunteers":733,"sex":739,"minAge":98,"maxAge":740,"enrollmentInfo":741,"targetDuration":98,"studyType":744,"phases":745,"briefSummary":747,"conditions":748,"keywords":751,"overallStatus":140,"whyStopped":98,"lastUpdateSubmitDate":755,"lastUpdatePostDateStruct":756,"startDateStruct":759,"completionDateStruct":761,"leadSponsor":763,"locationsCount":764},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":67},[9],{"measure":10,"description":11,"timeFrame":12},"SpO2>80","Proportion of infants with pre-ductal SpO2 \\>80%","At 5 minutes of life",[14,17,21,24,27,30,33,36,40,43,47,50,53,56,60,63],{"measure":15,"description":15,"timeFrame":16},"Heart rate","At 5 minutes after birth",{"measure":18,"description":19,"timeFrame":20},"Number of infants who received CPAP \u003C10min","Number of infants who received continuous positive airway pressure","Within 10 minutes after birth",{"measure":22,"description":23,"timeFrame":20},"Number of infants who received PPV \u003C10min","Number of infants who received positive pressure ventilation",{"measure":25,"description":26,"timeFrame":20},"Number of infants who were intubated \u003C10min","Number of infants who were endotracheally intubated",{"measure":28,"description":29,"timeFrame":20},"Number of infants who received chest compressions \u003C10min","Number of infants who received chest compressions \\\u003C10min",{"measure":31,"description":32,"timeFrame":20},"Number of infants who were administered adrenaline \u003C10min","Adrenaline use",{"measure":34,"description":35,"timeFrame":20},"Number of infants who were administered volume expansion \u003C10min","Number of infants who were administered volume expansion \\\u003C10minv",{"measure":37,"description":38,"timeFrame":39},"Max FiO2","Maximum FiO2","In the first 10 minutes after birth",{"measure":41,"description":42,"timeFrame":20},"Death \u003C10min","Death \\\u003C10min",{"measure":44,"description":45,"timeFrame":46},"Number of infants who were supported by CPAP in first week","CPAP use in the NICU","In the first week after birth",{"measure":48,"description":49,"timeFrame":46},"Number of infants who received surfactant in first week","Surfactant administration via INSURE, LISA or ET tube",{"measure":51,"description":52,"timeFrame":46},"Surfactant doses","Number of surfactant doses administered",{"measure":54,"description":55,"timeFrame":46},"Number of infants who were mechanically ventilated","Mechanical ventilation",{"measure":57,"description":58,"timeFrame":59},"Number of infants with abnormalities on the first cranial ultrasound","Abnormalities on first cranial ultrasound (IVH\u002FPVL)","In first week after birth",{"measure":61,"description":62,"timeFrame":46},"Death","Mortality",{"measure":64,"description":65,"timeFrame":66},"Cord clamping time","The time after birth at which the cord is clamped","During resuscitation at birth",[68,72,75,78,80,84,87,90],{"measure":69,"description":70,"timeFrame":71},"Congenital anomalies","Whether the infant has congenital anomalies, e.g. diaphragmatic hernia, oesophageal atresia, cyanotic heart disease","At birth",{"measure":73,"description":74,"timeFrame":71},"Gestational age","gestational age in weeks and days",{"measure":76,"description":77,"timeFrame":71},"Gender","Gender of the infant",{"measure":79,"description":79,"timeFrame":71},"Mode of delivery",{"measure":81,"description":82,"timeFrame":83},"Doses of antenatal steroids","Number of doses of antenatal steroids administered","Before birth",{"measure":85,"description":86,"timeFrame":83},"Maternal magnesium sulphate","Whether maternal magnesium sulphate was administered",{"measure":88,"description":89,"timeFrame":83},"Maternal general anaesthesia","Whether maternal general anaesthesia was administered",{"measure":91,"description":92,"timeFrame":83},"Complications during pregnancy","Whether there were any complications during pregnancy, e.g. premature prolonged rupture of membranes, chorioamnionitis, pre-eclampsia, placental abruption, twin-to-twin transfusion syndrome, hydrops fetalis, feto-maternal haemorrhage",{"allocation":94,"interventionModel":95,"interventionModelDescription":96,"primaryPurpose":97,"observationalModel":98,"timePerspective":98,"maskingInfo":99},"RANDOMIZED","PARALLEL","This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation.","TREATMENT",null,{"masking":100,"maskingDescription":101,"whoMasked":102},"SINGLE","Centres will be randomised for the fortnight at which they will switch their tactile stimulation practice from selective stimulation to repetitive stimulation. The analysing researcher will be blinded for the allocation of treatment switch.",[103],"OUTCOMES_ASSESSOR","Rationale: A randomised study demonstrated that preterm infants who received repetitive stimulation at birth (10 second episodes of stroking of the soles of the feet and\u002For back, followed by 10 seconds rest) showed an increase in respiratory effort. This may in turn improve clinical outcomes as improved breathing effort may reduce the need for invasive respiratory support. Tactile stimulation can be immediately and easily performed at birth at no extra cost. It therefore has great potential to be implemented in delivery rooms (DRs) worldwide.\n\nObjective: To determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.\n\nStudy design: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.\n\nStudy population: Infants born before 32 weeks of gestation will be included in this trial.\n\nIntervention: At the start of the study, each participating centre will perform selective tactile stimulation in accordance with international guidelines, as is their usual practice. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. In the second stage of the study, centres will be randomised to switch their stimulation approach to repetitive stimulation. Clinicians will then gently rub the back, chest, extremities or soles of the feet for 10 seconds. To avoid extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds of rest (no stimulation). Repetitive stimulation will be performed for the first 5 minutes of life, or longer if the breathing is still considered insufficient or absent.\n\nMain study parameter: The proportion of infants with pre-ductal oxygen saturation (SpO2) ≥ 80%.",[106,112],{"label":107,"type":108,"description":109,"interventionNames":110},"Selective stimulation","ACTIVE_COMPARATOR","At the start of the study, selective tactile stimulation will be performed at each participating centre in accordance with international guidelines. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.",[111],"Procedure: Selective tactile stimulation",{"label":113,"type":114,"description":115,"interventionNames":116},"Repeated stimulation","EXPERIMENTAL","For each centre, a lot will be drawn which indicates the month in which the protocol for tactile stimulation changes from selective stimulation to repetitive stimulation.\n\nRepetitive stimulation is defined as gently rubbing the soles of the feet, back, chest, or extremities for 10 seconds. To prevent extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds rest (no stimulation). The repetitive stimulation will be performed for the first 5 minutes after birth, or longer if the breathing is still considered insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.",[117],"Procedure: Repeated tactile stimulation",[119,124],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":98},"PROCEDURE","Repeated tactile stimulation","See arm",[113],{"type":120,"name":125,"description":122,"armGroupLabels":126,"otherNames":98},"Selective tactile stimulation",[107],[128,133],{"name":129,"role":130,"phone":131,"phoneExt":98,"email":132},"Janneke Dekker, PhD","CONTACT","+31715266620","j.dekker@lumc.nl",{"name":134,"role":130,"phone":135,"phoneExt":98,"email":136},"Colm O'Donnell, MD PhD","+35316373100","codonnell@nmh.ie",[138,157,172,188,201,215,224,239,252,267,280,293,308,323,333,346,359,374,388,398,410,425,439,452,467,480,490,503,516,529,544,556,569,581,594,607,622,637,650,663,682,696,711],{"facility":139,"status":140,"city":141,"state":98,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"Medical University of Graz","RECRUITING","Graz","8036","Austria","AT",{"type":146,"coordinates":147},"Point",[148,149],15.44197,47.06733,{"lat":149,"lon":148},[152,155],{"name":153,"role":130,"phone":154,"phoneExt":98,"email":98},"Nariae Baik-Schneditz, MD PhD","+433163850",{"name":153,"role":156,"phone":98,"phoneExt":98,"email":98},"PRINCIPAL_INVESTIGATOR",{"facility":158,"status":140,"city":159,"state":98,"zip":98,"country":160,"countryCode":161,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Liège University Hospital","Liège","Belgium","BE",{"type":146,"coordinates":163},[164,165],5.56749,50.63373,{"lat":165,"lon":164},[168],{"name":169,"role":130,"phone":170,"phoneExt":98,"email":171},"Vincent Rigo","+32 4 323 00 00","vincent.rigo@chu.ulg.ac.be",{"facility":173,"status":140,"city":174,"state":98,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Clinical Hospital Center Rijeka","Rijeka","51000","Croatia","HR",{"type":146,"coordinates":179},[180,181],14.44241,45.32673,{"lat":181,"lon":180},[184,187],{"name":185,"role":130,"phone":186,"phoneExt":98,"email":98},"Iva Bilic Cace, MD PhD","+38551658111",{"name":185,"role":156,"phone":98,"phoneExt":98,"email":98},{"facility":189,"status":140,"city":190,"state":98,"zip":98,"country":176,"countryCode":177,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Clinical Center Split","Split",{"type":146,"coordinates":192},[193,194],16.43915,43.50891,{"lat":194,"lon":193},[197],{"name":198,"role":130,"phone":199,"phoneExt":98,"email":200},"Anet Papazovska Cherepnalkovski","+385 21 556 111","anet.cherepnalkovski@gmail.com",{"facility":202,"status":140,"city":203,"state":98,"zip":98,"country":204,"countryCode":98,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"General Faculty Hospital in Prague","Prague","Czechia",{"type":146,"coordinates":206},[207,208],14.42076,50.08804,{"lat":208,"lon":207},[211],{"name":212,"role":130,"phone":213,"phoneExt":98,"email":214},"Tereza Lamberska","+420 224 967 732","lamberska.tereza@gmail.com",{"facility":216,"status":140,"city":203,"state":98,"zip":98,"country":204,"countryCode":98,"cosmosGeoPoint":217,"geoPoint":219,"contacts":220},"Institute for Mother and Child Care",{"type":146,"coordinates":218},[207,208],{"lat":208,"lon":207},[221],{"name":222,"role":130,"phone":98,"phoneExt":98,"email":223},"Milena Tuskova, MD","milena.tuskova@upmd.eu",{"facility":225,"status":140,"city":226,"state":98,"zip":98,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Aarhus University Hospital","Aarhus","Denmark","DK",{"type":146,"coordinates":230},[231,232],10.21076,56.15674,{"lat":232,"lon":231},[235],{"name":236,"role":130,"phone":237,"phoneExt":98,"email":238},"Ulla Christensen","+45 78 45 00 00","ullachri@rm.dk",{"facility":240,"status":140,"city":241,"state":98,"zip":98,"country":227,"countryCode":228,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Rigshospitalet Copenhagen","Copenhagen",{"type":146,"coordinates":243},[244,245],12.56553,55.67594,{"lat":245,"lon":244},[248],{"name":249,"role":130,"phone":250,"phoneExt":98,"email":251},"Christian Heiring","+45 35 45 35 45","christian.Heiring@regionh.dk",{"facility":253,"status":140,"city":254,"state":98,"zip":98,"country":255,"countryCode":256,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"University Hospital Carl Gustav Carus","Dresden","Germany","DE",{"type":146,"coordinates":258},[259,260],13.73832,51.05089,{"lat":260,"lon":259},[263],{"name":264,"role":130,"phone":265,"phoneExt":98,"email":266},"Mario Ruediger","+49 351 4580","mario.ruediger@uniklinikum-dresden.de",{"facility":268,"status":140,"city":269,"state":98,"zip":98,"country":255,"countryCode":256,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"University Hospital Dusseldorf","Düsseldorf",{"type":146,"coordinates":271},[272,273],6.77927,51.22319,{"lat":273,"lon":272},[276],{"name":277,"role":130,"phone":278,"phoneExt":98,"email":279},"Janna-Lina Kerth","+49 211 8100","Janna-Lina.Kerth@med.uni-duesseldorf.de",{"facility":281,"status":140,"city":282,"state":98,"zip":98,"country":255,"countryCode":256,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"University Hospital Tubingen","Tübingen",{"type":146,"coordinates":284},[285,286],9.05222,48.52266,{"lat":286,"lon":285},[289],{"name":290,"role":130,"phone":291,"phoneExt":98,"email":292},"Laila Springer","+49 7071 290","laila.springer@med.uni-tuebingen.de",{"facility":294,"status":140,"city":295,"state":98,"zip":98,"country":296,"countryCode":297,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Aristotle University of Thessaloniki","Thessaloniki","Greece","GR",{"type":146,"coordinates":299},[300,301],22.93493,40.64072,{"lat":301,"lon":300},[304],{"name":305,"role":130,"phone":306,"phoneExt":98,"email":307},"Kosmas Sarafidis","+30 231 099 6000","kosmas.sarafidis@gmail.com",{"facility":309,"status":140,"city":310,"state":98,"zip":98,"country":311,"countryCode":312,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"First dept of Obstetrics and Gynaecology, Semmelweis University","Budapest","Hungary","HU",{"type":146,"coordinates":314},[315,316],19.04045,47.49835,{"lat":316,"lon":315},[319],{"name":320,"role":130,"phone":321,"phoneExt":98,"email":322},"Peter Varga","+36 1 266 0473","pterv79@gmail.com",{"facility":324,"status":140,"city":310,"state":98,"zip":98,"country":311,"countryCode":312,"cosmosGeoPoint":325,"geoPoint":327,"contacts":328},"Second Semmelweis University",{"type":146,"coordinates":326},[315,316],{"lat":316,"lon":315},[329],{"name":330,"role":130,"phone":331,"phoneExt":98,"email":332},"Zsuzsanna Nagy","+36 1 215 1380","zsuzsanagydr@gmail.com",{"facility":334,"status":140,"city":335,"state":98,"zip":98,"country":311,"countryCode":312,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"University of Debrecen","Debrecen",{"type":146,"coordinates":337},[338,339],21.62444,47.53167,{"lat":339,"lon":338},[342],{"name":343,"role":130,"phone":344,"phoneExt":98,"email":345},"Tamas Kovacs","+36 52 512 900","kovacst@med.unideb.hu",{"facility":347,"status":140,"city":348,"state":98,"zip":98,"country":311,"countryCode":312,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Bács-Kiskun County Teaching Hospital","Szeged",{"type":146,"coordinates":350},[351,352],20.14824,46.253,{"lat":352,"lon":351},[355],{"name":356,"role":130,"phone":357,"phoneExt":98,"email":358},"Gyula Talosi","+36 78 564 001","talosigy@gmail.com",{"facility":360,"status":140,"city":361,"state":98,"zip":98,"country":362,"countryCode":363,"cosmosGeoPoint":364,"geoPoint":368,"contacts":369},"Landspitali University Hospital","Reykjavik","Iceland","IS",{"type":146,"coordinates":365},[366,367],-21.89541,64.13548,{"lat":367,"lon":366},[370],{"name":371,"role":130,"phone":372,"phoneExt":98,"email":373},"Sonja Baldursdottir","+354 543 1000","sonjab@landspitali.is",{"facility":375,"status":140,"city":376,"state":98,"zip":377,"country":378,"countryCode":379,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"National Maternity Hospital","Dublin","D02 YH21","Ireland","IE",{"type":146,"coordinates":381},[382,383],-6.24889,53.33306,{"lat":383,"lon":382},[386,387],{"name":134,"role":130,"phone":135,"phoneExt":98,"email":136},{"name":134,"role":156,"phone":98,"phoneExt":98,"email":98},{"facility":389,"status":140,"city":376,"state":98,"zip":98,"country":378,"countryCode":379,"cosmosGeoPoint":390,"geoPoint":392,"contacts":393},"Coombe Women & Infants University Hospital",{"type":146,"coordinates":391},[382,383],{"lat":383,"lon":382},[394],{"name":395,"role":130,"phone":396,"phoneExt":98,"email":397},"Jan Miletin","+353 1 408 5200","jmiletin@coombe.ie",{"facility":399,"status":140,"city":400,"state":98,"zip":98,"country":378,"countryCode":379,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"University Hospital Galway","Galway",{"type":146,"coordinates":402},[403,404],-9.05095,53.27245,{"lat":404,"lon":403},[407],{"name":408,"role":130,"phone":98,"phoneExt":98,"email":409},"Johannes Letshwiti, MD","jletshwiti@yahoo.co.uk",{"facility":411,"status":140,"city":412,"state":98,"zip":98,"country":413,"countryCode":414,"cosmosGeoPoint":415,"geoPoint":419,"contacts":420},"Ospedale dei Bambini Vittore Buzzi","Milan","Italy","IT",{"type":146,"coordinates":416},[417,418],9.18951,45.46427,{"lat":418,"lon":417},[421],{"name":422,"role":130,"phone":423,"phoneExt":98,"email":424},"Francesco Cavigioli","+39 02 63631","francesco.cavigioli@asst-fbf-sacco.it",{"facility":5,"status":140,"city":426,"state":427,"zip":428,"country":429,"countryCode":430,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"Leiden","South Holland","2333ZA","Netherlands","NL",{"type":146,"coordinates":432},[433,434],4.49306,52.15833,{"lat":434,"lon":433},[437,438],{"name":129,"role":130,"phone":131,"phoneExt":98,"email":132},{"name":129,"role":156,"phone":98,"phoneExt":98,"email":98},{"facility":440,"status":140,"city":441,"state":98,"zip":98,"country":429,"countryCode":430,"cosmosGeoPoint":442,"geoPoint":446,"contacts":447},"Erasmus MC Sophia Kinderziekenhuis","Rotterdam",{"type":146,"coordinates":443},[444,445],4.47917,51.9225,{"lat":445,"lon":444},[448],{"name":449,"role":130,"phone":450,"phoneExt":98,"email":451},"Ronny Knol","+31 10 704 0704","r.knol@erasmusmc.nl",{"facility":453,"status":140,"city":454,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":457,"geoPoint":461,"contacts":462},"Haukeland University Hospital","Bergen","Norway","NO",{"type":146,"coordinates":458},[459,460],5.32415,60.39299,{"lat":460,"lon":459},[463],{"name":464,"role":130,"phone":465,"phoneExt":98,"email":466},"Hans J Guthe","+47 55 97 50 00","Hans.Guthe@uib.no; hjgu@helse-bergen.no",{"facility":468,"status":140,"city":469,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":470,"geoPoint":474,"contacts":475},"Oslo University Hospital, Ulleval","Oslo",{"type":146,"coordinates":471},[472,473],10.74609,59.91273,{"lat":473,"lon":472},[476],{"name":477,"role":130,"phone":478,"phoneExt":98,"email":479},"Siv Fredly","+47 22 11 80 80","uxsidl@ous-hf.no",{"facility":481,"status":140,"city":469,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":482,"geoPoint":484,"contacts":485},"Oslo University Hospital",{"type":146,"coordinates":483},[472,473],{"lat":473,"lon":472},[486],{"name":487,"role":130,"phone":488,"phoneExt":98,"email":489},"Anne L Solevag","+47 23 07 00 00","a.l.solevag@medisin.uio.no",{"facility":491,"status":140,"city":492,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":493,"geoPoint":497,"contacts":498},"Stavanger University Hospital","Stavanger",{"type":146,"coordinates":494},[495,496],5.73332,58.97005,{"lat":496,"lon":495},[499],{"name":500,"role":130,"phone":501,"phoneExt":98,"email":502},"Peder Bjorland","+47 51 51 80 00","peder.aleksander.bjorland@sus.no",{"facility":504,"status":140,"city":505,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":506,"geoPoint":510,"contacts":511},"University Hospital of North Norway","Tromsø",{"type":146,"coordinates":507},[508,509],18.95508,69.6489,{"lat":509,"lon":508},[512],{"name":513,"role":130,"phone":514,"phoneExt":98,"email":515},"Claus Klingenberg","+47 77 62 60 00","claus.klingenberg@unn.no",{"facility":517,"status":140,"city":518,"state":98,"zip":98,"country":455,"countryCode":456,"cosmosGeoPoint":519,"geoPoint":523,"contacts":524},"St Olav's Hospital Trondheim","Trondheim",{"type":146,"coordinates":520},[521,522],10.39506,63.43049,{"lat":522,"lon":521},[525],{"name":526,"role":130,"phone":527,"phoneExt":98,"email":528},"Ragnhild Stoen","+47 72 57 30 00","ragnhild.stoen@stolav.no",{"facility":530,"status":140,"city":531,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":534,"geoPoint":538,"contacts":539},"Jan Biziel University Hospital No. 2 in Bydgoszcz","Bydgoszcz","Poland","PL",{"type":146,"coordinates":535},[536,537],18.00762,53.1235,{"lat":537,"lon":536},[540],{"name":541,"role":130,"phone":542,"phoneExt":98,"email":543},"Iwona Sadowska-Krawczenko","+48 52 365 57 99","sadowskakrawczenko@gmail.com; iga.rupniak@gmail.com",{"facility":545,"status":140,"city":546,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":547,"geoPoint":551,"contacts":552},"Medical University of Gdansk","Gdansk",{"type":146,"coordinates":548},[549,550],18.64912,54.35227,{"lat":550,"lon":549},[553],{"name":554,"role":130,"phone":98,"phoneExt":98,"email":555},"Joanna Jassem-Bobowicz, MD PhD","asiaj@gumed.edu.pl",{"facility":557,"status":140,"city":558,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":559,"geoPoint":563,"contacts":564},"Medical University of Silesa","Katowice",{"type":146,"coordinates":560},[561,562],19.02173,50.2597,{"lat":562,"lon":561},[565],{"name":566,"role":130,"phone":567,"phoneExt":98,"email":568},"Iwona Maruniak-Chudek","+48 32 208 36 00","ich@mp.pl",{"facility":570,"status":140,"city":571,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":572,"geoPoint":576,"contacts":577},"University of Medical Sciences","Poznan",{"type":146,"coordinates":573},[574,575],16.92993,52.40692,{"lat":575,"lon":574},[578],{"name":579,"role":130,"phone":98,"phoneExt":98,"email":580},"Tomasz Szczapa, MD PhD","tszczapa@ump.edu.pl",{"facility":582,"status":140,"city":583,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":584,"geoPoint":588,"contacts":589},"Provincial Hospital","Rzeszów",{"type":146,"coordinates":585},[586,587],21.99901,50.04132,{"lat":587,"lon":586},[590],{"name":591,"role":130,"phone":592,"phoneExt":98,"email":593},"Witold Blaz","+48 17 866 40 00","witekblaz@yahoo.com",{"facility":595,"status":140,"city":596,"state":98,"zip":98,"country":532,"countryCode":533,"cosmosGeoPoint":597,"geoPoint":601,"contacts":602},"Wrocław Medical University","Wroclaw",{"type":146,"coordinates":598},[599,600],17.03006,51.10286,{"lat":600,"lon":599},[603],{"name":604,"role":130,"phone":605,"phoneExt":98,"email":606},"Barbara Krolak-Olejnik","+48 71 733 11 10","olejnik.basia@gmail.com",{"facility":608,"status":140,"city":609,"state":98,"zip":98,"country":610,"countryCode":611,"cosmosGeoPoint":612,"geoPoint":616,"contacts":617},"Hospital de Braga","Braga","Portugal","PT",{"type":146,"coordinates":613},[614,615],-8.42311,41.5514,{"lat":615,"lon":614},[618],{"name":619,"role":130,"phone":620,"phoneExt":98,"email":621},"Almerinda Barroso Pereira","+351 253 027 000","almerindabarrosopereira@gmail.com",{"facility":623,"status":140,"city":624,"state":98,"zip":98,"country":625,"countryCode":626,"cosmosGeoPoint":627,"geoPoint":631,"contacts":632},"University Ovidius of Constanta","Constanța","Romania","RO",{"type":146,"coordinates":628},[629,630],28.63432,44.18073,{"lat":630,"lon":629},[633],{"name":634,"role":130,"phone":635,"phoneExt":98,"email":636},"Irina Franciuc","+40 241-605002","irina.franciuc@yahoo.ro",{"facility":638,"status":140,"city":639,"state":98,"zip":98,"country":625,"countryCode":626,"cosmosGeoPoint":640,"geoPoint":644,"contacts":645},"Clinical County Emergency Hospital Sibiu","Sibiu",{"type":146,"coordinates":641},[642,643],24.15,45.8,{"lat":643,"lon":642},[646],{"name":647,"role":130,"phone":648,"phoneExt":98,"email":649},"Maria Livia Ognean","+40 269-215-050","maria.ognean@ulbsibiu.ro",{"facility":651,"status":140,"city":652,"state":98,"zip":98,"country":625,"countryCode":626,"cosmosGeoPoint":653,"geoPoint":657,"contacts":658},"George Emil Palade University of Medicine","Târgu Mureş",{"type":146,"coordinates":654},[655,656],24.55747,46.54245,{"lat":656,"lon":655},[659],{"name":660,"role":130,"phone":661,"phoneExt":98,"email":662},"Manuela Cucerea","+40 265 262 275","manuelacucerea@yahoo.com",{"facility":664,"status":665,"city":666,"state":98,"zip":667,"country":668,"countryCode":669,"cosmosGeoPoint":670,"geoPoint":674,"contacts":675},"La Fe University Hospital","NOT_YET_RECRUITING","Valencia","46026","Spain","ES",{"type":146,"coordinates":671},[672,673],-0.37966,39.47391,{"lat":673,"lon":672},[676,679,680],{"name":677,"role":130,"phone":678,"phoneExt":98,"email":98},"Celia Barber Almenar","+34961244000",{"name":677,"role":156,"phone":98,"phoneExt":98,"email":98},{"name":681,"role":156,"phone":98,"phoneExt":98,"email":98},"Maximo Vento, MD PhD",{"facility":683,"status":140,"city":684,"state":98,"zip":98,"country":685,"countryCode":98,"cosmosGeoPoint":686,"geoPoint":690,"contacts":691},"University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul","Istanbul","Turkey (Türkiye)",{"type":146,"coordinates":687},[688,689],28.94966,41.01384,{"lat":689,"lon":688},[692],{"name":693,"role":130,"phone":694,"phoneExt":98,"email":695},"Tugce Goktas","+90 216 606 33 00","ntugcegoktas@gmail.com",{"facility":697,"status":140,"city":698,"state":98,"zip":98,"country":699,"countryCode":700,"cosmosGeoPoint":701,"geoPoint":705,"contacts":706},"Bukovyna State Medical University, Chernivtsi","Chernivtsi","Ukraine","UA",{"type":146,"coordinates":702},[703,704],25.93241,48.29045,{"lat":704,"lon":703},[707],{"name":708,"role":130,"phone":709,"phoneExt":98,"email":710},"Anastasiya Babintseva","+380 372 553 754","babintseva@bsmu.edu.ua",{"facility":712,"status":140,"city":713,"state":98,"zip":98,"country":699,"countryCode":700,"cosmosGeoPoint":714,"geoPoint":718,"contacts":719},"Sumy State University","Sumy",{"type":146,"coordinates":715},[716,717],34.79906,50.91741,{"lat":717,"lon":716},[720],{"name":721,"role":130,"phone":722,"phoneExt":98,"email":723},"Viktoriia Petrashenko","+380 542 334 058","v.petrashenko@med.sumdu.edu.ua",{"type":156,"investigatorFullName":725,"investigatorTitle":726,"investigatorAffiliation":5,"oldNameTitle":98,"oldOrganization":98},"Janneke Dekker","Principal Investigator",[728],{"name":729,"class":730},"European Society for Paediatric Research","UNKNOWN","100511706","the-neu-stim-trial-100511706",false,"NCT05942924","The NEU-STIM Trial","A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial","NEU-STIM","Inclusion Criteria:\n\n* Infants born before 32 weeks of gestation can be included in this trial after parental consent.\n\nExclusion Criteria:\n\n* Infants will be excluded if they are found to have a congenital abnormality or condition that has an adverse effect on breathing\u002Fventilation or oxygenation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.","ALL","32 Weeks",{"count":742,"type":743},3280,"ESTIMATED","INTERVENTIONAL",[746],"NA","The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.",[749,750],"Infant, Premature, Diseases","Birth, Preterm",[752,753,754],"Preterm infant","Tactile stimulation","Resuscitation","2025-03-05",{"date":757,"type":758},"2025-03-10","ACTUAL",{"date":760,"type":758},"2024-03-11",{"date":762,"type":743},"2025-12-31",{"name":5,"class":6},43]