L-Citrulline for BPD-related Pulmonary Hypertension in Preterm Babies
Official title: Safety and Pharmacodynamics of L-Citrulline for the Treatment of Pulmonary Hypertension (PH) in Preterm Neonates with Severe Bronchopulmonary Dysplasia (BPD-PH) [CToP BPD-PH]
Funded at Hackensack University Medical Center · NIH-11342260 · Data updated 2026-11-12
A first-in-human study will test safe and effective doses of L-citrulline given by mouth to stability-preterm infants at risk for lung blood pressure problems.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Hackensack University Medical Center NIH-funded |
| Lab location | 1 site (Hackensack, United States) |
| Project start | September 15, 2026 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $470,687 |
| NIH project number | 1R61HL185680-01 |
| Project ID | NIH-11342260 on NIH RePORTER |
Who could benefit from this research
✓Could help
Premature infants at high risk for BPD-PH who can tolerate enteral nutrition and are monitored at participating sites.
✕Less likely to help
Infants without BPD-PH risk factors or those intolerant to enteral L-citrulline may not benefit.
What this research studies
This study focuses on very young patients with bronchopulmonary dysplasia who are at high risk of developing pulmonary hypertension. It will test three different oral dosing strategies of L-citrulline to see how safe they are and how they affect nitric oxide pathways in the blood. The trial design is blinded and placebo-controlled across multiple sites to generate reliable pharmacodynamic and pharmacokinetic data. Results will help determine dosing for a future large trial that could improve lung health and outcomes for these vulnerable babies.
Why it matters
Potential benefit: If successful, the program could establish a safe dosing approach for L-citrulline that supports better lung blood flow in preterm infants at risk for BPD-PH.
How similar studies have gone: Prior infant studies show L-citrulline can be bioavailable with a favorable safety profile in long-term use, supporting this approach as promising.
Where this research is happening
-
Hackensack University Medical Center
Hackensack, United States Active
Researchers
- Principal investigator: Aschner, Judy Lynn — Hackensack University Medical Center
- Study coordinator: Aschner, Judy Lynn
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.