A Phase I Safety and Pharmacokinetics/Pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC

What this Trial Is About

Researchers are evaluating the safety and pharmacokinetics/pharmacodynamics (PK/PD) of oral L-Citrulline (L-CIT) supplementation in preterm infants with bronchopulmonary dysplasia (BPD) with or without pulmonary hypertension (PH), and those recovering from surgical necrotizing enterocolitis (NEC). These conditions involve inflammation and deficiencies in citrulline, arginine, or nitric oxide, which are important for blood flow and immune response in these vulnerable infants. The study includes two treatment groups. The first group of 18 infants with BPDPH receive L-CIT at a dose of 300 mg/kg/day divided every 6 hours. The second group of 18 infants recovering from stage III NEC start with 150 mg/kg/day divided every 6 hours for one week, escalating to 200 mg/kg/day if tolerated. For infants still needing respiratory support at 34 weeks gestation, the dose may increase to 300 mg/kg/day until 38 weeks postmenstrual age or discharge. Participants will be closely monitored over five years for safety and effects on inflammatory pathways. Assessments include blood pressure, stoma or nasogastric output, stool output, respiratory scores, biomarkers of inflammation and oxidative stress, ventilation status, BPD severity, mortality, steroid use, and infant development using Bayley’s scale. The study aims to gather detailed data on how L-CIT affects these outcomes in preterm infants at risk of these serious conditions.

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