IBP-9414 for the Prevention of Necrotizing Enterocolitis

Infant Bacterial Therapeutics

Status and phase: Completed; Phase 2

Conditions: Necrotizing Enterocolitis

Treatments: Drug: IBP-9414; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02472769

IBP-9414-010

Details and patient eligibility

About

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

Enrollment: 120 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

IBP-9414

Active Comparator group

Description:

IBP-9414 Oral Daily

Treatment:

Drug: IBP-9414

Placebo

Placebo Comparator group

Description:

Sterile water

Treatment:

Drug: Placebo