Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
Recruiting · NCT05636397 · Interventional (participants receive a specific treatment) · Lead sponsor: The Hospital for Sick Children
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 take part
Age range
1 Month to 6 Months
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- The Hospital For Sick Children - Toronto, Ontario, Canada