IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

  • STATUS
    Recruiting
  • End date
    Nov 8, 2022
  • participants needed
    2158
  • sponsor
    Infant Bacterial Therapeutics
Updated on 15 February 2022
Investigator
Anna Olsson, M.Sc.
Primary Contact
Maria Fareri Children's Hospital - Westchester Medical Center (2.7 mi away) Contact
+67 other location

Summary

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

Details
Condition Necrotizing Enterocolitis
Treatment Placebo, IBP-9414
Clinical Study IdentifierNCT03978000
SponsorInfant Bacterial Therapeutics
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
Birth weight 500-1500g
hours of age
Written informed consent from the subjects legally authorized representative (LAR)

Exclusion Criteria

Participation in any other interventional clinical trial
Infants in extremis to whom no further intensive care is offered by attending neonatologist
Infants with, or at a high probability for, early onset sepsis
Infants with recognized chromosomal anomalies
Congenital or acquired gastrointestinal disease
Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
Infants with known positive maternal HIV status
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