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Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

About

Brief Summary

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Other
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
1 Day
Maximum Age
5 Days

Inclusion Criteria:

  • Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
  • Birth weight ≥ 450g
  • Singleton or twin birth

Exclusion Criteria:

N/A

Study Stats
Protocol No.
26-0998
Category
Pediatric Disorders
Principal Investigator
Kara L. Calkins, MD
Kara L. Calkins, MD
Neonatology
Kara L. Calkins, MD
Contact
  • Margaret Bradley
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05904626
For detailed technical eligibility, visit ClinicalTrials.gov.