Patient population
death, congenital heart disease, fever, diarrhea, liver failure, ventricular septal defect, fetal anomalies, vomiting or, patent ductus arteriosus, BPD, atrial septal defect
LIVER FAILURE, PREMATURE, NECROTIZING ENTEROCOLITIS, ANEUPLOIDY
This study was the multiple-dose steady state arm of a phase I study NCT03542812 (PK of L-citrulline in infants at substantial risk of developing PH associated with BPD). The single-dose PK arm of the study has been previously published [We enrolled participants from two Newborn Intensive Care Units (NICUs) in Salt Lake City, UT, the University of Utah Hospital NICU and the Intermountain Medical Center NICU. The institutional review board for human subjects committee at each hospital approved the study protocol. Informed consent was obtained from the legal guardians of all subjects.Premature neonates born at ≤ 28 weeks gestation were eligible to be enrolled in the study if they required invasive mechanical ventilation or non-invasive positive pressure support (nasal continuous positive airway pressure or high flow nasal cannula ≥ 1 liter per minute) at 32 ± 1 week’s postmenstrual age. Other criteria included (1) the ability to tolerate at least one-half of full-volume oral/gavage tube feedings, using 120 ml/kg/d as full-volume oral/gavage tube feedings, (2) a need for some form of continuous respiratory support for the prior 14 days, and (3) a hemoglobin ≥ 10 mg/dl.Multiple births and infants with anticipated death prior to hospital discharge were excluded from the study. Also excluded were patients with any known major fetal anomalies, chromosomal aneuploidy, or clinical evidence of congenital heart disease, except for patent ductus arteriosus, atrial septal defect, or ventricular septal defect. Additional exclusion criteria were the presence of any acute illness as defined by a fever >100.4°, vomiting or diarrhea, a urine output < 1 ml/kg/hr., significant feeding intolerance beyond the first week of life, or a history of or known to have liver failure or necrotizing enterocolitis.