Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC (NCT05636397) | Clinical Trial Compass
RecruitingNot Applicable
Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Canada36 participantsStarted 2023-11-01
Plain-language summary
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 participate
Age range
1 Month – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Arm 1: BPD±PH:
Inclusion Criteria:
* 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)
Exclusion Criteria
* 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
Inclusion Criteria:
* 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 Criteria
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.