[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544701":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":52,"collaborators":19,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":19,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Isoleucine, leucine, valine, tryptophan requirement","EXPERIMENTAL","isoleucine, leucine, valine and tryptophan intakes will be varied in the TPN solutions to study the requirements for each of these amino acids in neonates that are TPN fed.",[13],"Drug: Total parenteral nutrition (TPN): this is total nutrition provided by central vein.",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Total parenteral nutrition (TPN): this is total nutrition provided by central vein.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Glenda Courtney-Martin, PhD","CONTACT","416 813 5744","glenda.courtney-martin@sickkids.ca",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Mahroukh Rafii, BSc","4168137454","mahroukh.rafii@sickkids.ca",[31],{"facility":32,"status":33,"city":34,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil","RECRUITING","Santa Maria","Brazil","BR",{"type":38,"coordinates":39},"Point",[40,41],-53.80694,-29.68417,{"lat":41,"lon":40},[44,48],{"name":45,"role":23,"phone":46,"phoneExt":19,"email":47},"Ivo Dr Prola, MD, PhD","6477815786","iprolla@gmail.com",{"name":49,"role":23,"phone":50,"phoneExt":19,"email":51},"Beatriz Dr Porto, MD","6475002171","bsilveiraporto@gmail.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Glenda Courtney-Martin","Principal Investigator","100544701","isoleucine-leucine-valine-and-tryptophan-requirements-in-tpn-fed-neonates-100544701",false,"NCT06372314","Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates","Isoleucine, Leucine, Valine and Tryptophan Requirements in Total Parenteral Nutrition (TPN) Fed Neonates","Inclusion Criteria:\n\n1. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein).\n2. TPN providing adequate calories and protein as determined by attending physician and dietitian.\n3. Babies born ≥ 28 weeks gestation,\n4. ≤ 28 days chronological age at the time of the study,\n5. Birth weight and length appropriate for gestational age,\n6. Medically stable as determined by normal blood results and lack of a fever or infection,\n7. At least 3 days after surgery, if the baby had a surgery\n\nExclusion Criteria:\n\n1. Babies on mechanical ventilation, on low flow oxygen and CPAP.\n2. Small for gestational age,\n3. On medications known to affect protein and amino acid metabolism,\n4. Documented infection, fever\n5. Unstable medical condition\n6. Receiving enteral feeding providing \\> 10% of protein intake","ALL","1 Day","28 Days",{"count":67,"type":68},80,"ESTIMATED","INTERVENTIONAL",[71],"NA","This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.\n\nThe investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates.",[74,75,76],"Neonates on TPN","Stable Neonates","Neonates Managed in the ICU",[78,79,80,81,82,83,84],"Neonates, Total pareteral nutrition (TPN), Isoleucine, Leucine, Valine, Tryptophan","neonates","parenteral nutrition","isoleucine","leucine","valine","tryptophan","2026-03-27",{"date":87,"type":88},"2026-04-02","ACTUAL",{"date":90,"type":88},"2026-01-01",{"date":92,"type":68},"2027-12",{"name":5,"class":6},1]