Born early, breathe easy

Respiratory Health Outcomes in Neonates - A randomised, double blind, double-dummy placebo-controlled trial of inhaled treatment to establish the mechanisms of prematurity-associated airway obstruction and inflammation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14767962

Enrollment

200

Registered

2016-02-12

Start date

2016-05-01

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity-associated respiratory disease Neonatal Diseases

Interventions

Random assignment to using one of the three following metered-dose inhalers 1. Fluticasone proprionate 2. Fluticasone proprionate/salmeterol xinafoate combination 3. Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 7-12 at the time of screening 2. Born at a gestational age =34 weeks (NB. Approximately n=50 term controls will also be invited) 3. Resident in the south Wales area whom, in the opinion of the Investigator, are possible to follow up 4. Fully informed proxy consent from parents/guardians and assent from child where possible

Exclusion criteria

Exclusion criteria: 1. Respiratory tract infection within the last three 3 weeks (will be asked to consider participating at a later date) 2. Congenital abnormalities 3. In the opinion of the Investigator have: 3.1. Severe cardiopulmonary defects, or 3.2. Neuromuscular disease, or 3.3. Severe neurodevelopmental impairment Which prohibit the possibility of compliance with the study protocol

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the difference in pre and post treatment percent predicted FEV1 after 12 weeks of therapy between the active and placebo groups	—

Secondary

Measure	Time frame
1. Differences in measures of obstructive airway disease (pulmonary function tests) 2. Differences in response to exercise challenge between treatment groups. 3. Differences in biomarkers of airway inflammation between treatment groups 4. Differences in respiratory and neurological symptoms (questionnaire) 5. MRI parameters: apparent diffusion coefficient (ADC) between 3 comparison groups (preterm, FEV1 =85% at baseline; preterm control, FEV1 ±1 standard deviation from normal; and term control, FEV1 ±1 standard deviation from normal). 6. Pre- and- post treatment differences in objectively measured physical activity 7. Adverse events All outcomes to be measured after 12 weeks of therapy between the active and placebo groups	—

Measure

Time frame

1. Differences in measures of obstructive airway disease (pulmonary function tests) 2. Differences in response to exercise challenge between treatment groups. 3. Differences in biomarkers of airway inflammation between treatment groups 4. Differences in respiratory and neurological symptoms (questionnaire) 5. MRI parameters: apparent diffusion coefficient (ADC) between 3 comparison groups (preterm, FEV1 =85% at baseline; preterm control, FEV1 ±1 standard deviation from normal; and term control, FEV1 ±1 standard deviation from normal). 6. Pre- and- post treatment differences in objectively measured physical activity 7. Adverse events All outcomes to be measured after 12 weeks of therapy between the active and placebo groups

—

Countries

United Kingdom, Wales

Contacts

Public ContactAlison Jenkins

RHINO@bangor.ac.uk+44 (0)1248 382442

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026