Respiratory Health Outcomes in Neontates

Phase 1

• Conditions: prematurity-related airway obstruction and inflammation; MedDRA version: 21.1Level: PTClassification code 10067775Term: Upper airway obstructionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10006464Term: BronchoconstrictionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003712-20-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

Part 1:
1)Children aged 7-12 at the time of screening
2)Born at a gestational age =34 weeks (NB. sufficient numbers of term-born participants to enroll n=100 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

Part 2
1)As part 1
plus
2)Preterm-born children found during part 1 to have FEV1 =85% predicted
NB. Approximately N=100 preterm-born and N=100 term-born controls with %FEV1 >85% predicted will also be invited to Part 2 visit 1

Part 3
1)Preterm-born children found to have FEV1 =85% at baseline laboratory visit (part 2, visit 1) who participated in the treatment trial
2)Willing to travel to the University of Sheffield Academic Unit of Radiology, Royal Hallamshire Hospital
NB. Approximately n=20 preterm-born and n=20 term-born controls (all with normal lung function) will also be invited to Part 3

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Part 1
1)Respiratory tract infection within the last three 3 weeks (will be re-invited at a later date)
2)Congenital abnormalities
3)In the opinion of the Investigator:
severe cardiopulmonary defects, or
neuromuscular disease, or
severe neurodevelopmental impairment
Which prohibit the possibility of compliance with the study protocol

Part 2
1)As part 1
plus
2)Known hypersensitivity to salmeterol and/or fluticasone

Part 3
1)Surgery of any type in the previous 2 months
2)Previous brain surgery involving placement of clips or shunts
3)Eye injuries resulting from metal fragments
4)Presence of any metal implants including pacemakers
5)Possibility to be or known to be pregnant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified