BALLOON-FU V1.0
Research type
Research Study
Full title
Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants: Follow up studies
IRAS ID
365334
Contact name
Sailesh Kotecha
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period thus putting them at risk of significant lung disease in child- and adult-hood including premature development of chronic obstructive pulmonary disease. At discharge from the neonatal unit, the pre-existing lung disease is exacerbated by frequent respiratory viral infections requiring far greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-RSV antibody prophylaxis, but in term-born infants trained immunity-based vaccines such as Bactek (MV130) are increasingly used.BALLOON is investigating 542 babies born <30 weeks gestation to determine if treatment from 37-43 weeks of gestation or discharge, if earlier, up to one year of corrected age with Bactek, can decrease the risk of an unscheduled visits to health care professionals for Lower Respiratory Tract Infections, compared to placebo. For the BALLOON-FU study, we hypothesise that (a) there will be continuing effect of the Bactek for at least six months after treatment has stopped after administration during the first year, and (b) there are no neurodevelopmental safety issues with the active treatment at two years of corrected age.
To address these hypotheses, we shall assess the following using questionnaires completed by the parents or clinical data from GP and hospital records:
1. Does Bactek, when compared with placebo, improve the longer-term respiratory outcomes (including lower respiratory tract infections, hospital admissions, respiratory drug usage, etc. during second year of life and wheezing (primary outcome) at 18 months and 2 years of corrected age for preterm-born infants recruited to the main BALLOON trial?
2. Does Bactek, when compared with placebo, affect the long-term neurodevelopmental outcomes of preterm-born children at 2 years of corrected age?
3. Does Bactek, when compared with placebo,improve the growth of preterm-born infants in the second years of life?REC name
East of Scotland Research Ethics Service REC 1
REC reference
26/ES/0032
Date of REC Opinion
17 Apr 2026
REC opinion
Further Information Favourable Opinion