Actively Recruiting
Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Led by The Hospital for Sick Children · Updated on 2026-05-04
36
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born at or before 30 weeks gestation
- Post-menstrual age of at least 32 weeks for BPD±PH group
- Echocardiographic evidence of pulmonary hypertension for infants with BPD+PH
- Receiving invasive or non-invasive ventilation with respiratory severity score greater than 2.0 for more than 12 hours/day for at least 48 hours (BPD±PH group)
- Recovering from Stage IIIb necrotizing enterocolitis requiring surgery (surgical NEC group)
- Tolerating 50 ml/kg/day of enteral feeds (surgical NEC group)
- Informed written consent obtained from parents or substitute decision makers
- Considered medically stable by clinical team (surgical NEC group)
You will not qualify if you...
- Congenital heart disease except small atrial septal defect, small ventricular septal defect, or small patent ductus arteriosus
- Pulmonary vein stenosis
- Concurrent sepsis with hemodynamic instability
- Infant likely to die within the next 7 days
- Any other condition that may affect ability to complete the study or pose significant risk to the infant
- Conditions significantly affecting pulmonary function independent of prematurity or NEC (surgical NEC group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
Research Team
R
Rachana Patel, MSc, CCRP
CONTACT
J
Jeffrey Antwi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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