Recruiting

Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC

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.

ClinicalTrials.gov IDNCT05636397
PhaseNA
Enrollment36
SponsorThe Hospital for Sick Children
Age1 Month
SexALL
I'm interested View official listing

Conditions studied

BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension, NEC

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.