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.

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 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

ISRCTN14019493.

Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.

This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.

Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.

MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.

Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays

Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I² and pooled estimates calculated with 95% CIs using the Wilson (score) method.

Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I², 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.

Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.

IS 2024 CRD42024558385.