Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Recruiting now NCT05636397
Run by The Hospital for Sick Children · for 1 Month month to 6 Months months · All sexes
What this study 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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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)
🚫 You may not be able to join if…
- 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
- 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
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- Congenital heart disease (except small ASD, small VSD and non hsPDA)
- Pulmonary vein stenosis
- Concurrent sepsis with hemodynamic instability
- Likely to die within next 7 days
- Other condition significantly affecting pulmonary function independent of prematurity or NEC
Where this trial is running
- The Hospital For Sick Children, Toronto, Ontario, Canada
Who to contact
Rachana Patel, MSc, CCRP · +1(416)-813-7654 · rachana.patel@sickkids.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05636397.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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