NCT05636397 Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
| NCT ID | NCT05636397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | BPD - Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-11-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Estelle Gauda, MD
PRINCIPAL INVESTIGATOR
Division Head, Division of Neonatology
Frequently Asked Questions
Who can join the NCT05636397 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 6 Months, studying BPD - Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05636397 currently recruiting?
Yes, NCT05636397 is actively recruiting participants. Contact the research team at rachana.patel@sickkids.ca for enrollment information.
Where is the NCT05636397 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05636397 clinical trial?
NCT05636397 is sponsored by The Hospital for Sick Children. The principal investigator is Estelle Gauda, MD at Division Head, Division of Neonatology. The trial plans to enroll 36 participants.