Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
Conditions
Interventions
Product Name: IBP-9414
Product Code: IBP-9414
Pharmaceutical Form: Powder for oral suspension
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Sponsors
Infant Bacterial Therapeutics AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Gestational age =32 weeks (determined by fetal ultrasound in 1st trimester if available, first day of last menstrual period and best obstetric estimate). 2.Birth weight: 1,001 – 2,000 g (Cohorts A & B); 500 – 1,000 g (Cohorts C & D). 3.=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: To assess safety and tolerability in premature infants given IBP-9414 at two doses, 1x10^8 and 1 x 10^9 CFU vs. placebo in two birth weight categories 1,000 – 2,000 g and 500 – 1,000 g ;Secondary Objective: No secondary objectives;Primary end point(s): The observed number of adverse events (AEs) and serious AEs (SAEs).;Timepoint(s) of evaluation of this end point: Days 7, 30 and 6 months after last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Sweden, United States
Contacts
Public ContactClinical trials information
Infant Bacterial Therapeutics AB
Outcome results
None listed