NCT05636397Recruiting
Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
A Phase I, Safety and Pharmacokinetics/Pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 26 Oct 2022
- Start date
- 1 Nov 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- The Hospital for Sick Children
- NCT number
- NCT05636397
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Nov 2023 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent sepsis with hemodynamic instability
- Concurrent sepsis with hemodynamic instability
Other illness
- 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
Other
- Infants with pulmonary vein stenosis
- Infants considered likely to die within next 7 days
- Pulmonary vein stenosis
- Likely to die within next 7 days
Who the study is looking for
- 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
Criteria the registry did not label
- Arm 1: BPD±PH:
Age in the registry: 1 month to 6 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.