None listed
Conditions
Brief summary
More than 15 million babies are born preterm each year. Life-long pulmonary consequences, including recurrent respiratory symptoms, airway obstruction, airway hyper-reactivity and declining lung function are especially evident in those born very preterm (<32 weeks gestation). However, there are no evidence-based interventions available or recommended to halt or reverse chronic lung disease in survivors of preterm birth after they leave the neonatal intensive care unit. This project aims to assess the effect of a 12-week treatment with inhaled corticosteroids (fluticasone propionate) on the lung function of children born very prematurely and identify the clinical features of those with a positive response to inhaled corticosteroid therapy.
Interventions
Fluticasone propionate
125 mcg twice daily for 12 weeks
Inhaled actuation. Parent-assisted, at-home administration.
Adherance will be recorded by participants and return of the product at the end of trial will allow for dose counting for each participant.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
Preterm-born participants: Children aged 6-12 years who were born at less than or equal to 32 weeks gestation, Healthy volunteers: Children aged 6-12 years who were born >37 weeks gestation who have no recurrent respiratory symptoms.
Exclusion criteria
• Severe congenital abnormalities • Severe cardiopulmonary defects • Severe neurodevelopmental impairment • Glucocorticoid use within the past 3 months
Outcome results
None listed