[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633271":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":25,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University College Dublin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: Anatomical facemask","EXPERIMENTAL","Anatomical facemask with a two-handed hold while giving facemask ventilation. The operators may be any member of the neonatal team, who have undergone NRP certification. Standardised mask size for gestation and weight, as per local policy, will be used. Educational sessions, including practical training, will be carried out prior to commencing the study to ensure all potential operators are familiar with both types of facemasks.",[13],"Device: Intervention: Anatomical facemask",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: Round facemask","ACTIVE_COMPARATOR","Round facemask with a two-handed hold while giving facemask ventilation. The operators may be any member of the neonatal team, who have undergone NRP certification. Standardised mask size for gestation and weight, as per local policy, will be used.",[19],"Device: Control: Round facemask",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Anatomical facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Round facemask, with a two-handed hold, to deliver positive pressure ventilation via a mask.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Laura J Ryan","CONTACT","+353851551609","laura.ryan5@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Eoin O'Currain","003531 6373498","eoinocurrain@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The National Maternity Hospital Dublin","RECRUITING","Dublin","Leinster","D02 YH21","Ireland","IE",{"type":49,"coordinates":50},"Point",[51,52],-6.24889,53.33306,{"lat":52,"lon":51},[55,57,59],{"name":31,"role":32,"phone":56,"phoneExt":25,"email":34},"0851551609",{"name":36,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":58,"phone":25,"phoneExt":25,"email":25},"Anna Curley",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100633271","neoshark-anatomical-versus-round-facemasks-for-breathing-support-in-preterm-and-term-newborn-infants-100633271",false,"NCT07524517","NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants","NeoSHARK: Neonatal Study of Two-Handed Anatomical Versus Round facemasK Ventilation in Preterm and Term Infants; a Randomised Controlled Trial","NeoSHARK","Inclusion Criteria:\n\n* All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication, and who require mask ventilation prior to intubation attempt.\n\nExclusion Criteria:\n\n* Neonates with a congenital malformation that would impact mask seal will not be included.","ALL",{"count":73,"type":74},50,"ESTIMATED","INTERVENTIONAL",[77],"NA","When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. There are various types of facemasks that can be used, including round and anatomical (triangular) masks, depending on the preference of the hospital, but it is unclear if one is better for the baby. Both types of facemasks are recommended in international guidelines, without any advice whether one is better than the other. Previous studies published by our research group demonstrated that a variety of different masks are used around the hospitals in Ireland. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that we are trying to give. We currently do not have enough evidence to say which type of mask is better to reduce the risk of this potential leaking of air.\n\nRecent studies have suggested that holding a mask with two hands (instead of one) is better in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in babies.\n\nIn this study, we will compare two different facemasks (round and anatomical) when holding the mask on a baby's face with two hands to help them breathe. We will randomly allocate each baby to either a round mask or an anatomical (triangular) mask and we will measure how much air leaks out around the mask during each breath. We will do this in babies who are in the neonatal unit.",[80],"Neonatal Intensive Care",[82,83,84,85,86,87,88,89],"Neonatology","Facemask ventilation","Face mask ventilation","Anatomical face mask","Round face mask","Two-handed mask hold","Two-handed facemask ventilation","Neonatal mask shape comparison","2026-05-07",{"date":92,"type":93},"2026-05-12","ACTUAL",{"date":95,"type":74},"2026-05",{"date":97,"type":74},"2027-02",{"name":5,"class":6},1]