A randomised, double-blind, parallel group, placebo controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants
Not Applicable
- Conditions
- RespiratoryRespiratory outcomes after premature birth including lower respiratory tract infections and wheeze.
- Registration Number
- ISRCTN14019493
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 542
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
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 BALLOO
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>Corrected age” is calculated using the expected date of delivery, therefore taking the degree (number of weeks of prematurity) into account.<br><br>An LRTI will be defined as:<br>Fever (=38°C) or a runny nose (rhinitis) for at least 12 hours, plus one additional symptom from the following: <br>moist cough<br>wheezing<br>shortness of breath<br>tachypnoea<br>intercostal recession<br>poor feeding<br><br>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 Outcome Measures
Name Time Method 1. Parent-reported wheeze episode between 37 weeks’ corrected age and 1-year corrected age. <br>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. <br>2. Parent-reported use of respiratory medications including bronchodilators, antibiotics and systemic corticosteroids <br>3. Parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant <br>4. Volume of adverse reactions <br>5. Identification of virus(es) associated with LRTIs<br>6. Growth (weight, length and head circumference)