Respiratory outcomes after premature birth including lower respiratory tract infections and wheeze. Respiratory
Conditions
Interventions
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 poly
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/03/2025: The presence/absence of parent-reported, health professional-confirmed unscheduled visits for LRTIs to GPs, A&Es and hospital admissions between 37-43 weeks’ corrected age (or discharge if earlier) and one-year corrected age. Previous primary outcome measure: The number of parent-reported, health professional-confirmed unscheduled visits for LRTIs to GPs, A&Es, paediatric assessment units and hospital admissions between 37 weeks’ corrected age (or discharge if earlier) and 1-year corrected age “Corrected age” is calculated using the expected date of delivery, therefore taking the degree (number of weeks of prematurity) into account. An LRTI will be defined as: Fever (=38°C) or a runny nose (rhinitis) for at least 12 hours, plus one additional symptom from the following: moist cough wheezing shortness of breath tachypnoea intercostal recession poor feeding The LRTI will be considered to be a new episode if there is an intervening period of at least 72 hours between episodes when the infant is well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/03/2025: 1. Number of parent-reported, health professional-confirmed unscheduled visits for LRTIs to GPs, A&Es and hospital admissions between 37 weeks’ corrected age (or discharge if earlier) and one-year corrected age. 2. Time to first episode of parent-reported, health professional-confirmed unscheduled visits for LRTIs to GPs, A&Es and hospital admissions between 37-43 weeks’ corrected age (or discharge if earlier) and one-year corrected age. 3. Parent-reported wheeze episode between 37-43 weeks’ corrected age or discharge if earlier and one-year corrected age. Wheeze episode is defined as an episode of wheezing: 1. that lasts at least one day with a sign of increased work of breathing such as shortness of breath, cough, or chest retraction or with any combination of these additional symptoms. 1.1 To establish the effect of Bactek on growth between the two groups 1.2 Parent-reported use of respiratory medications including bronchodilators, antibiotics and systemic corticosteroids 1.3 Parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant 1.4 Volume of adverse reactions 1.5 Identification of virus(es) associated with LRTIs Previous secondary outcome measures: 1. Parent-reported wheeze episode between 37 weeks’ corrected age and 1-year corrected age. Wheeze episode is defined as an episode of wheezing that lasts at least one day with a sign of increased work of breathing such as shortness of breath, cough, or chest retraction or with any combination of these additional symptoms. A WheezeScan device will be provided to parent(s)/guardian(s) and may be used to help parents detect these symptoms. 2. Parent-reported use of respiratory medications including bronchodilators, antibiotics and systemic corticosteroids 3. Parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant 4. Volume of adverse reactions 5. Identification of virus(es) assoc | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactSailesh;Sarah Kotecha;Kotecha
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Outcome results
None listed