[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488152":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":42,"responsibleParty":61,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BPD±PH","EXPERIMENTAL","Arm 1: BPD±PH\n\nTotal of 18 infants at 300 mg\u002Fkg\u002Fday divided q6 hours",[13],"Dietary Supplement: L-Citrulline",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical NEC","Arm 2: sNEC\n\nA total of 18 infants with Stage III NEC:\n\nDose Level 1 = 150 mg\u002Fkg\u002Fday divided q6 hours for one week. If study participant tolerates 150mg\u002Fkg\u002Fday well, then escalate the same study participant to Dose 2 after 1 week of starting Citrulline.\n\nDose Level 2 = 200 mg\u002Fkg\u002Fday divided q6 hours At 34 weeks of gestation, if baby is still on respiratory support of \\>250ml\u002Fmin of Low flow oxygen, then we will escalate to the dose of 300mg\u002Fkg\u002Fday and continue until 38 weeks PMA or until discharge, whichever is earlier.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","L-Citrulline","Citrulline is a nonessential amino acid made in the small intestine, occurs naturally in the body, and is believed to help reduce inflammation.L-CIT is a part of the urea cycle, produced as a by-product along with nitric oxide (NO).",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Estelle Gauda, MD","Division Head, Division of Neonatology","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Rachana Patel, MSc, CCRP","CONTACT","+1(416)-813-7654","202821","rachana.patel@sickkids.ca",{"name":38,"role":33,"phone":39,"phoneExt":40,"email":41},"Jeffrey Antwi","+1(416-)813-7654","202919","jeffrey.antwi@sickkids.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Hospital For Sick Children","RECRUITING","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58],{"name":59,"role":33,"phone":24,"phoneExt":24,"email":60},"Principal investigator","estelle.gauda@sickkids.ca",{"type":29,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Estelle Gauda","Head, Division of Neonatology","100488152","safety-and-pk-pd-study-of-oral-l-cit-in-preterm-infants-with-bpdph-and-nec-100488152",false,"NCT05636397","Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC","A Phase I, Safety and Pharmacokinetics\u002FPharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC","Arm 1: BPD±PH:\n\nInclusion Criteria:\n\n* Born ≤ 30 weeks at birth\n* Post-menstrual age (PMA) ≥ 32 weeks\n* Echocardiographic evidence of PH for infants with BPD+PH.\n* On invasive or non-invasive ventilation with RSS \\>2.0 for \\>12hours\u002Fday for at least 48 hours as an early predictor of evolving BPD\n* Informed written consent (parents\u002Fsubstitute decision maker)\n\nExclusion Criteria\n\n* Congenital Heart Disease \\[Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)\\]\n* Infants with pulmonary vein stenosis\n* Concurrent sepsis with hemodynamic instability\n* Infants considered likely to die within next 7 days\n* Any other condition that, in the opinion of the investigator, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant\n\nArm 2: surgical NEC\n\nInclusion Criteria:\n\n* Born ≤ 30 weeks at birth\n* Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)\n* Tolerating 50 ml\u002Fkg\u002Fday of enteral feeds\n* Informed written consent (parents\u002Fsubstitute decision maker)\n* Considered medically stable by clinical team\n\nExclusion Criteria\n\n* Congenital heart disease (except small ASD, small VSD and non hsPDA)\n* Pulmonary vein stenosis\n* Concurrent sepsis with hemodynamic instability\n* Likely to die within next 7 days\n* Other condition significantly affecting pulmonary function independent of prematurity or NEC","ALL","1 Month","6 Months",{"count":75,"type":76},36,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this study is to evaluate the safety and explore the PK\u002FPD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post-surgical NEC and BPD±PH.",[82,83,84],"BPD - Bronchopulmonary Dysplasia","Pulmonary Hypertension","NEC",[9,86,21,87,88,89],"surgical NEC","Pharmacokinetic profile","Pharmacodynamic profile","Preterm neonates","2026-04-28",{"date":92,"type":93},"2026-05-04","ACTUAL",{"date":95,"type":93},"2023-11-01",{"date":97,"type":76},"2028-03",{"name":5,"class":6},1]