[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558011":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":33,"locations":42,"responsibleParty":64,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Aga Khan University Hospital, Pakistan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"sodium acetate","EXPERIMENTAL",null,[13],"Drug: sodium acetate group will receive sodium acetate in the neonatal PN.",{"label":15,"type":16,"description":11,"interventionNames":17},"Sodium Chloride","ACTIVE_COMPARATOR",[18],"Drug: sodium chloride group will receive sodium chloride in the neonatal PN.",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","sodium acetate group will receive sodium acetate in the neonatal PN.","This group will receive sterile sodium acetate daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.",[9],[26],"Sodium Acetate",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"sodium chloride group will receive sodium chloride in the neonatal PN.","This group will receive sterile sodium chloride daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.",[15],[32],"sodium Chloride",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Gul Ambreen, PhD","CONTACT","+92 3002402035","gul.ambreen@aku.edu",{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},"Adnan Mirza, MBBS","adnan.mirza@aku.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Aga Khan University Hospital","RECRUITING","Karachi","Sindh","74800","Pakistan","PK",{"type":52,"coordinates":53},"Point",[54,55],67.0104,24.8608,{"lat":55,"lon":54},[58,59,60,62],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":40,"role":36,"phone":11,"phoneExt":11,"email":41},{"name":35,"role":61,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"name":40,"role":63,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Adnan Mirza","Clinical Assistant Professor","100558011","phase-3-prevention-of-metabolic-acidosis-in-preterm-neonates-by-replacing-sodium-chloride-with-sodium-acetate-in-parenteral-nutrition-100558011",false,"NCT06545565","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)","PROTECT","Inclusion Criteria:\n\n1. Written informed consent obtained by parents\u002Flegal representative (according to local regulations) before the initiation of PN.\n2. All the neonates who were admitted to the NICU of AKUH and received PN during 28 days of their life.\n3. Gestational age \\\u003C 33 weeks\n\nExclusion Criteria:\n\n1. Infants with an inborn error of metabolism\n2. Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)\n3. Severe metabolic alkalosis, in critically ill neonates, is defined as a persistent elevation of the serum pH above 7.45 and it also involves a primary increase in serum bicarbonate (HCO3-) concentration \\> 25mEq\u002FL.\n4. Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels \\> 150 mmol\u002FL\n5. Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia\n\n   \\-",true,"ALL","1 Day","3 Days",{"count":80,"type":81},200,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:\n\nIs the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations\u002Fguidelines of sodium acetate in daily PN, which are required to prevent\u002Ftreat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.\n\nIncluded Participants:\n\nAll the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.\n\nParticipants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents\u002Flegal representatives (according to local regulations) before the initiation of PN. Gestational age \\\u003C 33 weeks Included in the study before 72 hours of life",[87,88,89],"Metabolic Acidosis","Neonatal Disease","Neonatal Complication",[91,9,92,93],"metabolic acidosis","neonates","Parenteral Nutrition","2024-08-07",{"date":96,"type":97},"2024-08-09","ACTUAL",{"date":99,"type":97},"2024-07-10",{"date":101,"type":81},"2025-05-10",{"name":5,"class":6},1]