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.

Age: Newborn to 48 Hours old

Gender: All

Start Date: 07/04/2019

Primary Completion Date (Estimated): 06/01/2024

Study Completion Date (Estimated): 07/01/2024

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: Newborn to 48 Hours old

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days

* Birth weight 500-1500g

* ≤ 48 hours of age

* Written informed consent from the subject´s 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