A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study (20191002)

Your child was born, or is expected to be born, prematurely. Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants.

There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC. Infants with NEC are usually treated with bowel rest (stopping feeding by mouth), antibiotic medicines, and in some cases with surgery where the affected bowel needs to be removed. Some studies have shown that live bacteria given to the intestine of premature infants as early as possible in their life might be able to prevent NEC. Researchers want to find out if an investigational drug called “IBP-9414”, which is made of living bacteria, can help prevent NEC in prematurely born infants. An investigational drug is a drug that is being tested and is not approved for use and sale by any authorities like the U.S Food and Drug Administration [FDA].

Inclusion:

1. Gestational age at birth of 23 weeks+0 days - 32 weeks+0 days

2. Birth weight 500-1500g. (First infants with birth weights 750-1000g will be included. After a DMC recommendation, infants with birth weights 500-1000g will then be included. After 1400 subjects in the study, infants with birth weights 500-1500g will then be included.)

3. ≤ 48 hours of age

4. Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion:

1. Participation in any other interventional clinical trial
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. Infants with, or at a high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis (according to Higgins, 2016), and with the expectation of empirical antimicrobial therapy for > five days)
4. Infants with recognized chromosomal anomalies
5. Congenital or acquired gastrointestinal disease
6. Earlier or planned administration of formulas, foods or supplements that contain added live bacteria, including all infant formulas or food supplement products with added so-called ”probiotic” or added live bacterial content during the study
7. Infants with known positive maternal HIV statu