Necrotizing Enterocolitis
Conditions
Brief summary
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Interventions
DRUGIBP-9414
DRUGPlacebo
Sterile water
Sponsors
Infant Bacterial Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
Inclusion criteria
1. Gestational age ≤32 weeks 2. Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g. 3. \< 48 hours of age. 4. Written informed consent from the patient's legally authorized representative(s).
Exclusion criteria
1. Participation in an additional interventional clinical trial in which an investigational drug will be administered. 2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care). 3. Congenital or acquired gastrointestinal pathology. 4. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE) | 12 months |
Countries
United States
Outcome results
None listed