[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484714":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":25,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Specijalisticka Pedijatrijska Ordinacija prim.mr.sc. Maja Stimac, Specijalist Pedijatrije Sspecijalnosti Neonatologije","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preparation with hyaluronic acid","EXPERIMENTAL","Treatment of damaged nipple skin: Preparation with hyaluronic acid. The hyaluronic acid preparation will contain white vaseline and 0.2% sodium hyaluronate in a 30 g container.",[13],"Drug: Treatment of damaged nipple skin: Preparation with hyaluronic acid",{"label":15,"type":10,"description":16,"interventionNames":17},"Neutral Preparation without hyaluronic acid","Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid. The neutral preparation will contain white vaseline only, in a 30 g container, and wiil have the same appearance and fragrance as the active preparation.",[18],"Drug: Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Treatment of damaged nipple skin: Preparation with hyaluronic acid","The active preparation will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid","The neutral preparation, containing only white vaseline, will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.",[15],[31],{"name":32,"affiliation":33,"role":34},"Maja Štimac, MD; Mr.sc.","Specijalistička pedijatrijska ordinacija prim.mr.sc.Maja Štimac","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+385 98 799 188","maja@stimac.org",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Savjetovalište za dojenje, Dom zdravlja Osječko-baranjske županije","RECRUITING","Osijek","31000","Croatia","HR",{"type":49,"coordinates":50},"Point",[51,52],18.6942,45.55066,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":58},"Dragica Pavlović, mag.med.techn.","+385 99 815 47 60","dragica.pavlovic@dzobz.hr",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100484714","phase-4-hyaluronic-acid-for-the-treatment-of-damaged-nipples-in-breastfeeding-women-100484714",false,"NCT05591651","Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women","The Effectiveness of Hyaluronic Acid for the Treatment of Damaged Nipples in Breastfeeding Women: a Double-blind Randomised, Controlled Trial","Inclusion Criteria:\n\n* for mothers: a breastfeeding mother, living or residing in Osijek, with nipple skin damage (NTS 1, 2, 3, 4, or 5).\n* for babies: newborns from a singleton pregnancy, of gestational age from 37 to 42 weeks, with a birth weight of 2,500 to 4,500 grams.\n\nExclusion Criteria:\n\n* for mothers: mothers who do not breastfeed, mothers not living or residing in Osijek, mothers without nipple skin damage and mothers using other preparations for healing sore nipples (shells, pads).\n* for children: visible anomalies in the newborn which may affect the breastfeeding process, newborns that required admission to the neonatal unit","FEMALE",{"count":70,"type":71},160,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","Previous studies have shown that application of hyaluronic acid preparations to wounds of the skin and mucosa have a beneficial effect.\n\nThere is a lack of studies showing the effect of applying hyaluronic acid preparations to treat damaged nipple skin in breastfeeding mothers.\n\nThis study aims to determine the effect of applying a hyaluronic acid preparation to damaged nipple skin in breastfeeding women.",[77,78,79],"Cracked Nipple","Breastfeeding","Healing Wound",[81,82,83],"hyaluronic acid","cracked nipple","breastfeeding","2024-07-30",{"date":86,"type":87},"2024-07-31","ACTUAL",{"date":89,"type":87},"2023-01-09",{"date":91,"type":71},"2026-02",{"name":5,"class":6},1]