A Phase I, Safety and Pharmacokinetics/pharmacodynamics Study of Oral L-CIT Supplementation 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.
• Born ≤ 30 weeks at birth
• Post-menstrual age (PMA) ≥ 34 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
• Informed written consent (parents/substitute decision maker)
• Born ≤ 30 weeks at birth
• Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)
• Tolerating 30 ml/kg/day of enteral feeds
• On invasive or non-invasive ventilation (NIPPV/nCPAP) with RSS \>2.0 for \> 12hours/day for at least 48 hours, 10-14 days post surgery
• Informed written consent (parents/substitute decision maker)
• Considered medically stable by clinical team