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

Recruiting N/A Interventional Study
BPD - Bronchopulmonary Dysplasia Pulmonary Hypertension NEC
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
1 Month – 6 Months
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
36 (estimated)
Sponsor
The Hospital for Sick Children · Other
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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.

Trial Locations
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Eligibility Criteria
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 * I…
Contacts

Rachana Patel, MSc, CCRP

+1(416)-813-7654

rachana.patel@sickkids.ca

CONTACT

Jeffrey Antwi

+1(416-)813-7654

jeffrey.antwi@sickkids.ca

CONTACT