Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Congenital Heart Disease [Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)]
Infants with pulmonary vein stenosis
Concurrent sepsis with hemodynamic instability
Infants considered likely to die within next 7 days
Trial design
Treatments tested in this trial
- L-Citrulline
Treatment groups
36 Participants
are divided into 2 treatment groupsLocations
1The Hospital For Sick ChildrenM5G 1X8, TorontoOntario, Canada
Sponsors and collaborators
The Hospital for Sick Children
Lead sponsor
Source ClinicalTrials.gov