| Title: |
Randomised, double-blind, parallel group, placebo-controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants in the UK: BALLOON study - study protocol |
| Authors: |
Kotecha, Sarah Joanne; Lowe, John; Gillespie, David; Perez-Alijas, Mahuampi; Aboklaish, Ali F; Mahachi, Tarirai Lincoln; Cumming, Oliver Sebastian; Harris, Debbie; Hubbard, Marie; Thomas-Jones, Emma; Jones, Tim; Ladell, Kirsten; Moore, Catherine; Humpreys, Ian; Grigg, Jonathan; Berrington, Janet; Kotecha, Sailesh |
| Publisher Information: |
BMJ Publishing Group |
| Publication Year: |
2026 |
| Collection: |
Cardiff University: ORCA (Online Research @ Cardiff) |
| Description: |
Introduction A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age. Methods and analysis 542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://orca.cardiff.ac.uk/id/eprint/185799/1/e107929.full.pdf; Kotecha, Sarah Joanne https://orca.cardiff.ac.uk/view/cardiffauthors/A112252W.html, Lowe, John https://orca.cardiff.ac.uk/view/cardiffauthors/A3764114.html orcid:0000-0003-4772-1879 orcid:0000-0003-4772-1879, Gillespie, David https://orca.cardiff.ac.uk/view/cardiffauthors/A111852Z.html orcid:0000-0002-6934-2928 orcid:0000-0002-6934-2928, Perez-Alijas, Mahuampi https://orca.cardiff.ac.uk/view/cardiffauthors/A2718312M.html, Aboklaish, Ali F, Mahachi, Tarirai Lincoln https://orca.cardiff.ac.uk/view/cardiffauthors/A2751987T.html, Cumming, Oliver Sebastian https://orca.cardiff.ac.uk/view/cardiffauthors/A24802183.html, Harris, Debbie https://orca.cardiff.ac.uk/view/cardiffauthors/A1196482F.html orcid:0000-0002-7073-7724 orcid:0000-0002-7073-7724, Hubbard, Marie, Thomas-Jones, Emma, Jones, Tim, Ladell, Kirsten, Moore, Catherine https://orca.cardiff.ac.uk/view/cardiffauthors/A3017109T.html, Humpreys, Ian, Grigg, Jonathan, Berrington, Janet and Kotecha, Sailesh https://orca.cardiff.ac.uk/view/cardiffauthors/A075802D.html orcid:0000-0003-3535-7627 orcid:0000-0003-3535-7627 2026. Randomised, double-blind, parallel group, placebo-controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants in the UK: BALLOON study - study protocol. BMJ Open 16 (3) , e107929. 10.1136/bmjopen-2025-107929 https://doi.org/10.1136/bmjopen-2025-107929 file https://orca.cardiff.ac.uk/id/eprint/185799/1/e107929.full.pdf |
| DOI: |
10.1136/bmjopen-2025-107929 |
| Availability: |
https://orca.cardiff.ac.uk/id/eprint/185799/; https://doi.org/10.1136/bmjopen-2025-107929; https://orca.cardiff.ac.uk/id/eprint/185799/1/e107929.full.pdf |
| Rights: |
cc_by_4_0 |
| Accession Number: |
edsbas.1E9360B1 |
| Database: |
BASE |