Safety and Governance
Cross-source consensus on Safety and Governance from 1 sources and 5 claims.
1 sources · 5 claims
Risks & contraindications
Background
Other
Other
Highlighted claims
- No adverse events were reported during recruitment of four infants from March to May 2025. — 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
- The protocol version described is version 1.4 dated 4 June 2025, with ethics approval from Wales Research Ethics Committee 3. — 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
- After committee assessment, full recruitment started in June 2025. — 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
- Oversight is provided by an Independent Data Monitoring Committee, an independent Trial Steering Committee and a monthly Trial Management Group. — 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
- The protocol included a formal safety run-in despite prior Bactek use in preterm-born infants. — 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