Respiratory outcomes after premature birth including lower respiratory tract infections and wheeze.
The active IMP and the placebo are sublingual sprays. The placebo is identical to the active IMP except for the absence of the active ingredients. Active IMP: A sublingual spray comprising of a polybacterial preparation of heat-inactivated Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and Moraxella catarrhalis (Bactek™, Inmunotek, Spain). Placebo: A sublingual spray comprising of all excipients of the active IMP, aside from the inactivated bacteria. Dosage: 300 FTU/mL (2x 150 FTU/mL sprays), once daily, from 37 weeks corrected age or discharge if earlier up to 1 year of corrected age
Current participant inclusion criteria as of 07/03/2025: 1. Birth at gestational age ≤29+6 weeks’ 2. Follow-up is likely to be feasible 3. Survival to one year corrected age is anticipated 4. In addition to infants without an eventful course, the following groups are eligible for inclusion: 5. Infants diagnosed with bronchopulmonary dysplasia 6. Infants discharged home on oxygen 7. Infants who have had necrotising enterocolitis 8. Infants on oral or nasogastric tube feeding 9. Infants with treated patent ductus arteriosus 10. Infants with neurological disorders 11. Infants with resolved sepsis Previous participant inclusion criteria: 1. Birth at gestational age ≤29+6 weeks (including infants born as one of a multiple births) 2. In the opinion of the PI, follow-up is likely to be feasible (i.e routine outpatient appointments will be at the recruiting site, locality of baby’s residence so follow up to one year corrected age is possible.) 3. Survival to 1 year corrected of age is anticipated
Current participant inclusion criteria as of 07/03/2025: 1. Presence of major surgical, cardiac or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale) 2. Contraindication of Bactek™ as specified in the Investigator’s Brochure 3. Participation in other interventional trial that precludes participation in BALLOON 4. Primary immune deficiencies Previous participant inclusion criteria: 1. Presence of major surgical, cardiac or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale) 2. Contraindication of Bactek™ as specified in the Investigator’s Brochure 3. Participation in other interventional trial that precludes participation in BALLOON