Tests oral L-citrulline in preterm infants with lung disease or bowel disease
Tests oral L-citrulline in preterm infants with lung disease or bowel disease after surgery.
Plain-language title generated from the registry record
Registry title: Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Key facts
- Where
- Toronto, CanadaSee the site
Where in Canada
- The Hospital for Sick ChildrenToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Hospital for Sick Children
- Trial code
- NCT05636397
- Record updated
- 4 May 2026
- Original description
The purpose of this study is to evaluate the safety and explore the PK/PD 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.Read full original descriptionShow less
A Phase I, Safety and Pharmacokinetics/Pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC
The purpose of this study is to evaluate the safety and explore the PK/PD 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.
Inclusion: Born ≤ 30 weeks at birth; Post-menstrual age (PMA) ≥ 32 weeks; Echocardiographic evidence of PH for infants with BPD+PH; On invasive or non-invasive ventilation with RSS >2.0 for >12hours/day for at least 48 hours as an early predictor of evolving BPD; Informed written consent (parents/substitute decision maker); Born ≤ 30 weeks at birth; Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery); Tolerating 50 ml/kg/day of enteral feeds; Informed written consent (parents/substitute decision maker); Considered medically stable by clinical team.
Exclusion: Concurrent sepsis with hemodynamic instability; Concurrent sepsis with hemodynamic instability; Congenital Heart Disease [Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)]; 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; Arm 2: surgical NEC; Congenital heart disease (except small ASD, small VSD and non hsPDA); Other condition significantly affecting pulmonary function independent of prematurity or NEC; Infants with pulmonary vein stenosis; Infants considered likely to die within next 7 days; Pulmonary vein stenosis; Likely to die within next 7 days.
Arm 1: BPD±PH:.