Phase 1
Completed N=42
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
Bronchopulmonary Dysplasia · Bronchopulmonary Dysplasia Associated Pulmonary Hypertension · Hypertension · Premature Birth
Source: ClinicalTrials.gov NCT03649932 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change in Plasma Levels of L-arginine and L-citrulline as Measured by LCMS Approach — 24; 33; 26; 112 micromol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Levels of L-arginine and L-citrulline as Measured by LCMS Approach |
24; 33; 26; 112; 150; 171 | — |
| PRIMARY Safety of L-citrulline in Preterm Infants: Measured by at Least One Adverse Event |
0; 0; 0 | — |
| PRIMARY Number of Participants With an Increase Plasma Level of L-citrulline > 37 Micromol/L |
8; 10; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Infants less than or equal to 30 weeks' gestational age born at UTMB, Galveston.
- Parents have provided informed consent/assent in a manner that is approved by the IRB
Exclusion Criteria
- Known congenital or chromosomal anomalies.
- Congenital heart disease affecting cardio-respiratory system (other than PDA, PFO or ASD)
- Necrotizing enterocolitis, sepsis, or any condition requiring surgery prior to recruitment
Data sourced from ClinicalTrials.gov (NCT03649932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.