Evaluating L-Citrulline for Preterm Infants with Lung and Gut Issues
A Phase I, Safety and Pharmacokinetics/Pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC
NA · The Hospital for Sick Children · NCT05636397
This study is testing if giving L-Citrulline to preterm infants with lung and gut problems can help reduce inflammation and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 1 Month to 6 Months |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05636397 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and pharmacokinetics/pharmacodynamics (PK/PD) of L-Citrulline supplementation in preterm infants suffering from bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). Preterm infants are particularly vulnerable to inflammatory conditions due to their underdeveloped organs and immune systems. By supplementing with L-Citrulline, which has vasoprotective and anti-inflammatory properties, the study seeks to prevent inflammatory pathways that can lead to further complications. The trial will involve infants born at or before 30 weeks gestation who are experiencing specific health challenges related to BPD and NEC.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at or before 30 weeks gestation who are experiencing BPD with pulmonary hypertension or recovering from surgical NEC.
Not a fit: Patients with congenital heart disease or those who are critically ill and unlikely to survive in the next week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to reduce inflammation and improve outcomes in preterm infants with BPD and NEC.
How similar studies have performed: While the specific use of L-Citrulline in this context is novel, similar approaches targeting inflammatory pathways in preterm infants have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- The Hospital For Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Estelle Gauda, MD — Division Head, Division of Neonatology
- Study coordinator: Rachana Patel, MSc, CCRP
- Email: rachana.patel@sickkids.ca
- Phone: +1(416)-813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension, NEC, BPD±PH, surgical NEC, L-Citrulline, Pharmacokinetic profile, Pharmacodynamic profile