Recruiting

L-CIT

Sponsor:

The Hospital for Sick Children

Code:

NCT05636397

Conditions

BPD - Bronchopulmonary Dysplasia

Pulmonary Hypertension

NEC

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

L-Citrulline

Study Details

Brief summary:

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.

Conditions

BPD - Bronchopulmonary Dysplasia

Pulmonary Hypertension

NEC

Study ID

NCT05636397

Start date

Nov 1, 2023

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: BPD±PH

Arm 1: BPD±PH

Total of 18 infants at 300 mg/kg/day divided q6 hours

experimental: Surgical NEC

Arm 2: sNEC

A total of 18 infants with Stage III NEC:

Dose Level 1 = 150 mg/kg/day divided q6 hours for one week. If study participant tolerates 150mg/kg/day well, then escalate the same study participant to Dose 2 after 1 week of starting Citrulline.

Dose Level 2 = 200 mg/kg/day divided q6 hours At 34 weeks of gestation, if baby is still on respiratory support of >250ml/min of Low flow oxygen, then we will escalate to the dose of 300mg/kg/day and continue until 38 weeks PMA or until discharge, whichever is earlier.

Interventions

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).

Primary outcome measure

  • Safety of oral L-Citrulline administration [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Rachana Patel, MSc, CCRP

+1(416)-813-7654rachana.patel@sickkids.ca

Jeffrey Antwi

+1(416-)813-7654jeffrey.antwi@sickkids.ca

Locations

The Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal investigator

estelle.gauda@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • BPD±PH
  • surgical NEC
  • L-Citrulline
  • Pharmacokinetic profile
  • Pharmacodynamic profile
  • Preterm neonates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-05-04.