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Amino Acid

Oral L-Citrulline for Bronchopulmonary Dysplasia and Necrotizing Enterocolitis

N/A

Recruiting

Led By Estelle Gauda, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menstrual age (PMA) ≥ 34 weeks

Echocardiographic evidence of PH for infants with BPD+PH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if supplementing preterm infants with an amino acid can help protect from serious diseases, like NEC and BPD.

Who is the study for?

This trial is for preterm infants born at or before 30 weeks, currently older than 34 weeks post-menstrual age. It's specifically for those with Bronchopulmonary Dysplasia (BPD) and/or Pulmonary Hypertension (PH), who need breathing support. Infants must have a Respiratory Severity Score (RSS) over 2 and be on ventilation more than half the day.

What is being tested?

The study tests L-Citrulline supplementation in these infants to prevent inflammation that can lead to severe lung conditions like BPD±PH and intestinal issues like Necrotizing Enterocolitis (NEC). The safety of this treatment and how it affects the body will be closely monitored.

What are the potential side effects?

As this trial aims to establish safety, potential side effects are not fully known but may include reactions related to digestion, growth, or metabolism given L-Citrulline's role in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby is at least 34 weeks in adjusted age since conception.

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My baby has heart issues related to lung problems.

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I've been on a ventilator for more than 12 hours a day for at least 2 days.

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I was born at or before 30 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of oral L-Citrulline administration

Secondary study objectives

Association of blood pressure as one of the PD outcomes with maximum L-CIT concentration (Cmax)

Association of blood pressure with minimum L-CIT concentration (Cmin)

Association of blood pressure with the area under the concentration time curve (AUC) for L-CIT

+19 more

Side effects data

From 2021 Phase 2 trial • 65 Patients • NCT04570384

Infusion Site Reaction

Deep Vein Thrombosis

Dyspnoea

Clostridium Difficile Infection

Urinary Tract Infection

Staphylococcal Sepsis; Alpha Haemolytic Streptococcal Infection

Pain In Extremity

Skin Wound

Acute kidney injury

Cardiac failure; metabolic acidosis

Chest pain; Dyspnoea; COVID-19

Intracranial hemorrhage

Acute Myocardial Infarction

Status epilepticus

Syncope

Enterococcal Infection

Enterococcus Test Positive

Epistaxis

Hypoglycaemia

Hypoxia

Tachycardia

Ventricular Extrasystoles

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Arm

IV L-Citrulline (Turnobi) Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Surgical NECExperimental Treatment1 Intervention

Arm 2: sNEC A total of 18-36 infants with Stage III NEC; 6-12 at each dose level of oral dosage form of L-Citrulline. (75, 150 or 225 mg/kg/day divided q6 hours) Dose Level 1 = 75 mg/kg/day Dose Level 2 = 150 mg/kg/day Dose Level 3 = 225 mg/kg/day

Group II: BPD±PHExperimental Treatment1 Intervention

Arm 1: BPD±PH Total of 12-24 infants; 6-12 at each dose level of oral dosage form of L-Citrulline. (300 or 500 mg/kg/day divided q6 hours). Dose Level 1 = 300 mg/kg/day Dose Level 2 = 500 mg/kg/day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-Citrulline

2023

Completed Phase 2

~350

0 / 4Eligibility criteria met