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Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment target: 60 to 36
    • Eligibility criteria shortened, about 14 words
    v5
  2. Study Identification, Study Statusv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to Nov 1, 2023
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 1 of 22 entries
    v3
  4. Start date: Feb 2023 to Jun 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05636397
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)		 BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension, NEC
Related terms Bronchopulmonary Dysplasia, Hypertension, Pulmonary
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov