A study for the investigation of safety of different doses of IBP-9414 that are randomly assigned to preterm infants

Conditions: Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-004228-70-SE

Lead Sponsor: Infant Bacterial Therapeutics AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

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.< 48 hours of age.
4.Written informed consent from the patient’s legally authorized representative(s).

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures