Testing L-Citrulline for BPD - bronchopulmonary dysplasia
Official title: Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC
A Phase I, Safety and Pharmacokinetics/Pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants With BPD±PH and NEC
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
L-Citrulline
Citrulline is a nonessential amino acid made in the small intestine, occurs naturally in the body, and is believed to help reduce inflammation.L-CIT is a part of the urea cycle, produced as a by-product along with nitric oxide (NO).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
The Hospital For Sick Children
Toronto, Ontario
Eligibility Criteria
See who this study is looking for42 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Born ≤ 30 weeks at birth
- +Post-menstrual age (PMA) ≥ 32 weeks
- +Echocardiographic evidence of PH for infants with BPD+PH.
- +On invasive or non-invasive ventilation with RSS \>2.0 for \>12hours/day for at least 48 hours as an early predictor of evolving BPD
- +Informed written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (parents/substitute decision maker)
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Congenital Heart Disease \[Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)\]
- +Infants with pulmonary vein stenosis
- +Concurrent sepsis with hemodynamic instability
- +Infants considered likely to die within next 7 days
- +Any other condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant
- +ArmArmOne of the groups in a study, each receiving something different.Read more → 2: surgical NEC
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +Born ≤ 30 weeks at birth
- +Tolerating 50 ml/kg/day of enteral feeds
- +Informed written consent (parents/substitute decision maker)
- +Considered medically stable by clinical team
- +Exclusion Criteria
- +Congenital heart disease (except small ASD, small VSD and non hsPDA)
- +Pulmonary vein stenosis
- +Concurrent sepsis with hemodynamic instability
- +Likely to die within next 7 days
- +Other condition significantly affecting pulmonary function independent of prematurity or NEC
- +Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)
Exclusion
- −Congenital Heart Disease \[Exceptions: small atrial septal defect (ASD), small ventricular septal defect (VSD), small patent ductus arteriosus (PDA)\]
- −Infants with pulmonary vein stenosis
- −Concurrent sepsis with hemodynamic instability
- −Infants considered likely to die within next 7 days
- −Any other condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant
- −ArmArmOne of the groups in a study, each receiving something different.Read more → 2: surgical NEC
- −Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −Born ≤ 30 weeks at birth
- −Tolerating 50 ml/kg/day of enteral feeds
- −Informed written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (parents/substitute decision maker)
- −Considered medically stable by clinical team
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- −Congenital heart disease (except small ASD, small VSD and non hsPDA)
- −Pulmonary vein stenosis
- −Concurrent sepsis with hemodynamic instability
- −Likely to die within next 7 days
- −Other condition significantly affecting pulmonary function independent of prematurity or NEC
- −Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive L-Citrulline.
Registry label: A: BPD±PH · B: Surgical NEC
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 1 month to 6 months.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 36 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety of oral L-Citrulline administration — measured over 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05636397 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About L-CitrullineDietary supplement
Citrulline is a nonessential amino acid made in the small intestine, occurs naturally in the body, and is believed to help reduce inflammation.L-CIT is a part of the urea cycle, produced as a by-product along with nitric oxide (NO).
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 1 month to 6 months.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 1 month to 6 months.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 years.
The study as a whole is currently expected to finish around 2028-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 36 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post-surgical NEC and BPD±PH.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.