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.

Arm 1: BPD±PH:Inclusion Criteria:Born ≤ 30 weeks at birthPost-menstrual age (PMA) ≥ 34 weeksEchocardiographic evidence of PH for infants with BPD+PHOn invasive or non-invasive ventilation with RSS >2.0 for >12hours/day for at least 48 hoursInformed 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 stenosisConcurrent sepsis with hemodynamic instabilityInfants considered likely to die within next 7 daysAny 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 NECInclusion CriteriaBorn ≤ 30 weeks at birthRecovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)Tolerating 30 ml/kg/day of enteral feedsOn invasive or non-invasive ventilation (NIPPV/nCPAP) with RSS >2.0 for > 12hours/day for at least 48 hours, 10-14 days post surgeryInformed written consent (parents/substitute decision maker)Considered medically stable by clinical teamExclusion Criteria:Congenital heart disease (except small ASD, small VSD and non hsPDA)Pulmonary vein stenosisConcurrent sepsis with hemodynamic instabilityLikely to die within next 7 daysOther condition significantly affecting pulmonary function independent of prematurity or NEC