CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Enteral L-citrullinedietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03649932
NCT03649932Phase 1Completed
CompareCT.gov

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

The University of Texas Medical Branch, Galveston·interventional·Posted Aug 28, 2018·Updated Oct 25, 2021

In Brief

A Phase 1 clinical trial evaluating Enteral L-citrulline for Bronchopulmonary Dysplasia and 4 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants. Since oral L-citrulline supplementation has never been studied in preterm infants before, the side effect profile and appropriate dosing are still unknown. In this pilot study, the investigators will determine the safety profile, efficacy and appropriate dosing of oral L-citrulline in preterm infants. In the future, information from this study will be utilized to conduct a randomized placebo-controlled trial to evaluate the role of L-citrulline supplementation in treating BPD\_PH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia, Bronchopulmonary Dysplasia Associated Pulmonary Hypertension, Pulmonary Hypertension, Premature Birth, Chronic Lung Disease of Prematurity
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 28, 2018
Enrollment StartSep 25, 2018
Primary CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.8 years ago

Interventions

Enteral L-citrullinedietary

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.