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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

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 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
9%
Infusion Site Reaction
6%
Deep Vein Thrombosis
6%
Dyspnoea
6%
Clostridium Difficile Infection
6%
Urinary Tract Infection
3%
Staphylococcal Sepsis; Alpha Haemolytic Streptococcal Infection
3%
Pain In Extremity
3%
Skin Wound
3%
Acute kidney injury
3%
Cardiac failure; metabolic acidosis
3%
Chest pain; Dyspnoea; COVID-19
3%
Intracranial hemorrhage
3%
Acute Myocardial Infarction
3%
Status epilepticus
3%
Syncope
3%
Enterococcal Infection
3%
Enterococcus Test Positive
3%
Epistaxis
3%
Hypoglycaemia
3%
Hypoxia
3%
Tachycardia
3%
Ventricular Extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Arm
IV L-Citrulline (Turnobi) Arm

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

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,817 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
331 Patients Enrolled for Bronchopulmonary Dysplasia
Estelle Gauda, MDPrincipal InvestigatorDivision Head, Division of Neonatology
~40 spots leftby Dec 2027
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