Preterm Paediatric Inhaled Corticosteroid Intervention (PICSI)
Inhaled corticosteroids for treating active lung disease in survivors of preterm birth
Telethon Kids Institute
250 participants
Oct 23, 2018
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria4
- Severe congenital abnormalities
- Severe cardiopulmonary defects
- Severe neurodevelopmental impairment
- Glucocorticoid use within the past 3 months
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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.
Locations(1)
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ACTRN12618000781246