Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 25, 2018

Primary Completion Date

June 21, 2021

Study Completion Date

June 21, 2021

Conditions
Bronchopulmonary DysplasiaBronchopulmonary Dysplasia Associated Pulmonary HypertensionPulmonary HypertensionPremature BirthChronic Lung Disease of Prematurity
Interventions
DIETARY_SUPPLEMENT

Enteral L-citrulline

"L-Citrulline as 10 % solution (100 mg/ml) will be provided to the bedside nurse by the Investigational Pediatric Pharmacy. The drug will be given via gavage feeding by bolus infusions followed by a 0.5 ml water flush twice daily (0900 and 2100). Bolus dosing will be needed due to the small volumes (0.5-1.5 ml per dose in most infants). The volume of nasogastric tubing used in preterm infants (Ameritus 4.0 Fr 50 cm) is 0.48 ml, therefore we will follow the administration with 0.5 ml of saline/water flush to ensure all the study drug is delivered to the patient.~Administration of study drug - Will be given via gavage feeding tube twice daily (0900 +/- 30 mins, 2100 +/- 30 mins). L-citrulline will be given by the bedside nurse as a bolus followed by 0.5 ml water flush. L-citrulline will be given separate from feeds to avoid any confusion.~Study drug will be started when infant has been off of TPN for at least 3 days so that IV arginine in TPN does not interfere."

Trial Locations (1)

77550

University of Texas Medical Branch, Galveston

All Listed Sponsors
lead

The University of Texas Medical Branch, Galveston

OTHER

NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing | Biotech Hunter | Biotech Hunter