Evaluating L-Citrulline for Preterm Infants with Lung and Gut Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and pharmacokinetics/pharmacodynamics (PK/PD) of L-Citrulline supplementation in preterm infants suffering from bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). Preterm infants are particularly vulnerable to inflammatory conditions due to their underdeveloped organs and immune systems. By supplementing with L-Citrulline, which has vasoprotective and anti-inflammatory properties, the study seeks to prevent inflammatory pathways that can lead to further complications. The trial will involve infants born at or before 30 weeks gestation who are experiencing specific health challenges related to BPD and NEC.

Why it matters

Who can join: the full rules

Arm 1: BPD±PH:

Inclusion Criteria:

* 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 consent (parents/substitute decision maker)

Exclusion Criteria

* 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 investigator, may adversely affect the infant's ability to complete the study or its measures or pose significant risk to the infant

Arm 2: surgical NEC

Inclusion Criteria:

* Born ≤ 30 weeks at birth
* Recovering from Stage IIIb NEC as per modified Bell's staging (pneumoperitoneum requiring surgery)
* 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

Where it's running

• The Hospital For Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Estelle Gauda, MD — Division Head, Division of Neonatology
• Study coordinator: Rachana Patel, MSc, CCRP
• Email: rachana.patel@sickkids.ca
• Phone: +1(416)-813-7654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.